IN_123_2022_english_compressed ANVISA BE
KarthikRajendran53
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Jun 11, 2024
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About This Presentation
Anvisa BABE Checklist
Slide Content
NORMATIVE INSTRUCTION - IN No. 123, OF MARCH 24, 2022
I- essential (I): item that meets the recommendations of good practices for bioavailability/bioequivalence of medicines, which can have a critical
influence on the quality or safety of the tests and on the safety of workers in their interaction with the products and processes during the performance of
studies;
(Published in DOU No. 61, of March 30, 2022)
Ministry of Health - MS
II- necessary (N): item that complies with the recommendations of Good Practices for Bioavailability/Bioequivalence of Medicines, which may
influence, to a lesser extent, the quality or safety of the tests and the safety of workers in their interaction with products and processes during the
performance of studies;
Approves the Inspection Guide for Medicine Bioavailability/Bioequivalence Centers.
National Health Surveillance Agency - ANVISA
This text does not replace the one(s) published in the Official Gazette.
The Collegiate Board of the National Health Surveillance Agency, in the use of the powers conferred by arts. 7, item III, and 15, items III and IV,
of Law No. 9782, of January 26, 1999, and considering the provisions of art. 187, item VII and §§ 1 and 3, of the Internal Regulations, approved by the
Resolution of the Collegiate Board of Directors - RDC No. 585, of December 10, 2021, resolves to adopt the following Normative Instruction, as decided at
a meeting held on March 23 2022, and I, Chief Executive Officer, determine its publication:
Art. 2 For the purposes of this Normative Instruction, the following definitions are adopted:
Art. 1 The inspection roadmap in centers of bioavailability/bioequivalence of medicines, contained in the ANNEX of this Normative Instruction,
pursuant to art. 4 of the Collegiate Board Resolution – RDC No. 56, of October 8, 2014, which provides for the Certification of Good Practices for carrying
out studies of bioavailability/bioequivalence of medicines, or any other that may replace it.
Machine Translated by Google
I- essential (I): item that meets the recommendations of good practices for bioavailability/bioequivalence of medicines, which can have a critical
influence on the quality or safety of the tests and on the safety of workers in their interaction with the products and processes during the performance of
studies;
(Published in DOU No. 61, of March 30, 2022)
Ministry of Health - MS
II- necessary (N): item that complies with the recommendations of Good Practices for Bioavailability/Bioequivalence of Medicines, which may
influence, to a lesser extent, the quality or safety of the tests and the safety of workers in their interaction with products and processes during the
performance of studies;
Approves the Inspection Guide for Medicine Bioavailability/Bioequivalence Centers.
National Health Surveillance Agency - ANVISA
This text does not replace the one(s) published in the Official Gazette.
The Collegiate Board of the National Health Surveillance Agency, in the use of the powers conferred by arts. 7, item III, and 15, items III and IV,
of Law No. 9782, of January 26, 1999, and considering the provisions of art. 187, item VII and §§ 1 and 3, of the Internal Regulations, approved by the
Resolution of the Collegiate Board of Directors - RDC No. 585, of December 10, 2021, resolves to adopt the following Normative Instruction, as decided at
a meeting held on March 23 2022, and I, Chief Executive Officer, determine its publication:
Art. 2 For the purposes of this Normative Instruction, the following definitions are adopted:
Art. 1 The inspection roadmap in centers of bioavailability/bioequivalence of medicines, contained in the ANNEX of this Normative Instruction,
pursuant to art. 4 of the Collegiate Board Resolution – RDC No. 56, of October 8, 2014, which provides for the Certification of Good Practices for carrying
out studies of bioavailability/bioequivalence of medicines, or any other that may replace it.
Machine Translated by Google
§ 1 The criterion established for the classification of the items in the inspection script is based on the potential risk inherent in each item in relation to the quality and safety
of the test and the safety of the worker in his interaction with the activities carried out, in order to guarantee the reliability of the results obtained.
§ 3 The item of the Inspection script considered necessary when not fulfilled in an inspection will be classified as essential in the following inspections.
IV- informative (INF): item that presents descriptive information, which does not affect the quality and safety of the tests and the safety of workers in their interaction with the
products and processes during the studies.
October 2014, Section 1, pg. 41.
§ 4 The item of the inspection script considered recommendable when not fulfilled in an inspection will be classified as necessary
Ministry of Health - MS
Art. 3 The administrative procedure regarding the inspection roadmap in bioavailability/bioequivalence centers must
This text does not replace the one(s) published in the Official Gazette.
National Health Surveillance Agency - ANVISA
in subsequent inspections, but will never be treated as essential.
observe the criteria established for the classification of the items in the itinerary set out in art. 2nd.
§ 2 The items of the inspection script can be answered by yes or no, or in a descriptive form, when appropriate.
Art. 4 Normative Instruction - IN No. 9, of October 8, 2014, published in the Federal Official Gazette No. 195, of October 9, is hereby revoked
III- recommended (R): item that meets the recommendations of good practices for bioavailability/bioequivalence of medicines, which may have a non-critical influence on the
quality or safety of the tests and on the safety of workers in their interaction with products and processes during the performance of studies; It is
Machine Translated by Google
of the test and the safety of the worker in his interaction with the activities carried out, in order to guarantee the reliability of the results obtained.
§ 3 The item of the Inspection script considered necessary when not fulfilled in an inspection will be classified as essential in the following inspections.
IV- informative (INF): item that presents descriptive information, which does not affect the quality and safety of the tests and the safety of workers in their interaction with the
products and processes during the studies.
October 2014, Section 1, pg. 41.
§ 4 The item of the inspection script considered recommendable when not fulfilled in an inspection will be classified as necessary
Ministry of Health - MS
Art. 3 The administrative procedure regarding the inspection roadmap in bioavailability/bioequivalence centers must
This text does not replace the one(s) published in the Official Gazette.
National Health Surveillance Agency - ANVISA
in subsequent inspections, but will never be treated as essential.
observe the criteria established for the classification of the items in the itinerary set out in art. 2nd.
§ 2 The items of the inspection script can be answered by yes or no, or in a descriptive form, when appropriate.
Art. 4 Normative Instruction - IN No. 9, of October 8, 2014, published in the Federal Official Gazette No. 195, of October 9, is hereby revoked
III- recommended (R): item that meets the recommendations of good practices for bioavailability/bioequivalence of medicines, which may have a non-critical influence on the
quality or safety of the tests and on the safety of workers in their interaction with products and processes during the performance of studies; It is
Machine Translated by Google
Art 5 This Normative Instruction comes into force on May 2, 2022.
Ministry of Health - MS
This text does not replace the one(s) published in the Official Gazette.
ANTONIO BARRA TORRES
National Health Surveillance Agency - ANVISA
Machine Translated by Google
Ministry of Health - MS
This text does not replace the one(s) published in the Official Gazette.
ANTONIO BARRA TORRES
National Health Surveillance Agency - ANVISA
Machine Translated by Google
What is the physical area of the inpatient ward?
As for the external appearance of the building(s) is it in good condition (free of cracks, leaks, etc.)?
1.1.7
No
No.
1.1.3
1. CLINICAL STAGE
Are there sources of pollution or environmental contamination close to the clinical unit?
R
ATTACHMENT
This text does not replace the one(s) published in the Official Gazette.
1.1.2
Is the lighting appropriate?
1.1.6
No
No
Ministry of Health - MS
Are the surroundings of the buildings clean?
1.1. FACILITIES - GENERAL CONDITIONS
1.1.5
1.1.1
Are the floors, walls and ceilings appropriate for the activities carried out in the area?
Which. Items
INSPECTION SCRIPT IN BIOAVAILABILITY/BIOEQUIVALENCE CENTERS
INF
1.1.4
Are the facilities constructed in such a way as to provide protection against the entry of insects and other animals?
National Health Surveillance Agency - ANVISA
INF
R
Machine Translated by Google
As for the external appearance of the building(s) is it in good condition (free of cracks, leaks, etc.)?
1.1.7
No
No.
1.1.3
1. CLINICAL STAGE
Are there sources of pollution or environmental contamination close to the clinical unit?
R
ATTACHMENT
This text does not replace the one(s) published in the Official Gazette.
1.1.2
Is the lighting appropriate?
1.1.6
No
No
Ministry of Health - MS
Are the surroundings of the buildings clean?
1.1. FACILITIES - GENERAL CONDITIONS
1.1.5
1.1.1
Are the floors, walls and ceilings appropriate for the activities carried out in the area?
Which. Items
INSPECTION SCRIPT IN BIOAVAILABILITY/BIOEQUIVALENCE CENTERS
INF
1.1.4
Are the facilities constructed in such a way as to provide protection against the entry of insects and other animals?
National Health Surveillance Agency - ANVISA
INF
R
Machine Translated by Google
Are they in appropriate hygienic conditions?
1.2.4 N
INF
Items
Items
1.2.3
What furniture and equipment are in the bed areas?
Which.
1.2.1
Which.
Is the ventilation of the inpatient ward adequate?
1.3.5
1.2. AUXILIARY FACILITIES
1.3.2N
Is access to employee toilets independent of the hospitalization areas?
1.2.6N
1.3.1
R
1.3.4
This text does not replace the one(s) published in the Official Gazette.
Is the area exclusive to volunteers during hospitalization periods?
Ministry of Health - MS
1.2.2N
No.
Are there enough toilets for employees (relate to area and number of employees)?
1.2.5
How is the distribution of beds, in a ward with several beds or in apartments?
Are there enough locker rooms for employees (relate to area and number of employees)?
No.
Is there an electricity generator for emergencies?
1.3. INTERNATION WING
1.3.3N
R
National Health Surveillance Agency - ANVISA
Are they in appropriate hygienic conditions?
Is the lighting in the inpatient ward appropriate?
INF
R
I
Machine Translated by Google
1.2.4 N
INF
Items
Items
1.2.3
What furniture and equipment are in the bed areas?
Which.
1.2.1
Which.
Is the ventilation of the inpatient ward adequate?
1.3.5
1.2. AUXILIARY FACILITIES
1.3.2N
Is access to employee toilets independent of the hospitalization areas?
1.2.6N
1.3.1
R
1.3.4
This text does not replace the one(s) published in the Official Gazette.
Is the area exclusive to volunteers during hospitalization periods?
Ministry of Health - MS
1.2.2N
No.
Are there enough toilets for employees (relate to area and number of employees)?
1.2.5
How is the distribution of beds, in a ward with several beds or in apartments?
Are there enough locker rooms for employees (relate to area and number of employees)?
No.
Is there an electricity generator for emergencies?
1.3. INTERNATION WING
1.3.3N
R
National Health Surveillance Agency - ANVISA
Are they in appropriate hygienic conditions?
Is the lighting in the inpatient ward appropriate?
INF
R
I
Machine Translated by Google
Do they have a doctor on duty at the study site during the entire period of hospitalization?
1.3.10 R
In the case of a mobile ICU, is there a pre-established fixed unit for transferring the volunteer?
1.3.16 I
What is the area of the infirmary?1.3.9
This text does not replace the one(s) published in the Official Gazette.
Are the toilets in hygienic conditions and are they provided with hot and/or cold water, soap, and towels or hairdryers?1.3.7 N
1.3.15 INF
1.3.19 INF
Are there enough toilets?
Is there an area for volunteer recreation?
Does the clinical unit have an ICU?
1.3.13 No
1.3.17 I
INF
What is the distance between the inpatient ward and the ICU?
Ministry of Health - MS
1.3.8N Is there a nursing station?
In the case of a mobile ICU, will it be available at the hospital during the period of greatest risk of serious adverse events?
Is there a rest area for the doctor?
1.3.11 I
1.3.20N
Is there a rest area for the nursing staff?
1.3.6N
Is the ICU system a mobile type or part of the clinical unit?
1.3.14 I
1.3.18 INF
1.3.12 R
National Health Surveillance Agency - ANVISA
Is there an office for volunteer evaluation?
Is there a cafeteria?
Machine Translated by Google
1.3.10 R
In the case of a mobile ICU, is there a pre-established fixed unit for transferring the volunteer?
1.3.16 I
What is the area of the infirmary?1.3.9
This text does not replace the one(s) published in the Official Gazette.
Are the toilets in hygienic conditions and are they provided with hot and/or cold water, soap, and towels or hairdryers?1.3.7 N
1.3.15 INF
1.3.19 INF
Are there enough toilets?
Is there an area for volunteer recreation?
Does the clinical unit have an ICU?
1.3.13 No
1.3.17 I
INF
What is the distance between the inpatient ward and the ICU?
Ministry of Health - MS
1.3.8N Is there a nursing station?
In the case of a mobile ICU, will it be available at the hospital during the period of greatest risk of serious adverse events?
Is there a rest area for the doctor?
1.3.11 I
1.3.20N
Is there a rest area for the nursing staff?
1.3.6N
Is the ICU system a mobile type or part of the clinical unit?
1.3.14 I
1.3.18 INF
1.3.12 R
National Health Surveillance Agency - ANVISA
Is there an office for volunteer evaluation?
Is there a cafeteria?
Machine Translated by Google
Is there UPS in the equipment for emergency?
1.5.2N
Which. Items
I
Is the distribution of equipment/instruments arranged in a rational manner?
1.5.1
1.4. EQUIPMENT
Which. Items
Are there thermometers? Conditions?
This text does not replace the one(s) published in the Official Gazette.
What furniture and equipment are available in the leisure area?
Do you have an oxygen mask?
1.5. OFFICE/NURSING
1.5.3
1.6. EMERGENCY CART
No.
Ministry of Health - MS
Is there a sphygmomanometer? Conditions?
Which. Items
I
No.
Are they periodically calibrated? What kind of calibration?
1.4.1 R
1.3.21 INF
No.
1.5.3
Is there a stethoscope? Conditions?
National Health Surveillance Agency - ANVISA
1.4.2 R
1.6.1I
I
Machine Translated by Google
1.5.2N
Which. Items
I
Is the distribution of equipment/instruments arranged in a rational manner?
1.5.1
1.4. EQUIPMENT
Which. Items
Are there thermometers? Conditions?
This text does not replace the one(s) published in the Official Gazette.
What furniture and equipment are available in the leisure area?
Do you have an oxygen mask?
1.5. OFFICE/NURSING
1.5.3
1.6. EMERGENCY CART
No.
Ministry of Health - MS
Is there a sphygmomanometer? Conditions?
Which. Items
I
No.
Are they periodically calibrated? What kind of calibration?
1.4.1 R
1.3.21 INF
No.
1.5.3
Is there a stethoscope? Conditions?
National Health Surveillance Agency - ANVISA
1.4.2 R
1.6.1I
I
Machine Translated by Google
1.6.3
1.7. SAMPLE PREPARATION ROOM
Is there a fridge?
R Is there a freezer?
1.6.6 Are there emergency medications? Which?
1.7.4N
Do you have a cuffed intubation cannula in good condition?
1.6.5
Is there a centrifuge? Is it refrigerated? Is it calibrated?
R
This text does not replace the one(s) published in the Official Gazette.
1.7.6 N
Do you have Ambu?
1.7.1
I
Are samples prepared in the clinical unit or sent to another unit?
Are there freezer temperature records? Are the thermometers used calibrated by a laboratory accredited by RBC?
I
1.7.5
1.7.8N Is there a record of the temperature of the refrigerators?
Ministry of Health - MS
Is there a procedure for cleaning and decontaminating the centrifuge?
Do you have disposable syringes?
1.6.4
Which. Items
1.7.3N
1.6.2
Do you have a laryngoscope?
Is there a room reserved for sample preparation?1.7.2
INF
National Health Surveillance Agency - ANVISA
I
No.
1.7.7
I
I
R
Machine Translated by Google
1.7. SAMPLE PREPARATION ROOM
Is there a fridge?
R Is there a freezer?
1.6.6 Are there emergency medications? Which?
1.7.4N
Do you have a cuffed intubation cannula in good condition?
1.6.5
Is there a centrifuge? Is it refrigerated? Is it calibrated?
R
This text does not replace the one(s) published in the Official Gazette.
1.7.6 N
Do you have Ambu?
1.7.1
I
Are samples prepared in the clinical unit or sent to another unit?
Are there freezer temperature records? Are the thermometers used calibrated by a laboratory accredited by RBC?
I
1.7.5
1.7.8N Is there a record of the temperature of the refrigerators?
Ministry of Health - MS
Is there a procedure for cleaning and decontaminating the centrifuge?
Do you have disposable syringes?
1.6.4
Which. Items
1.7.3N
1.6.2
Do you have a laryngoscope?
Is there a room reserved for sample preparation?1.7.2
INF
National Health Surveillance Agency - ANVISA
I
No.
1.7.7
I
I
R
Machine Translated by Google
Are volunteers' personal data handled within medical confidentiality?
1.8.5 N
Does the institution have a CEP?INF
Are all Protocols approved by the CEP before they start?
1.8.1N
Which. Items
1.8.2N
1.9. GOOD CLINICAL PRACTICES
1.9.5
1.8. DOCUMENTATION
This text does not replace the one(s) published in the Official Gazette.
Are/will volunteers' medical records be kept for a minimum period of five years?
1.9.4
Are the studies conducted in accordance with the protocol previously approved by the CEP?
1.8.4 INF
Is the researcher or any member of his team part of the CEP? If so, he abstains from judging his own
Ministry of Health - MS
1.8.3
Is there a clinical record of the study contemplating its particularities?
Are the study protocol and amendments submitted to the Research Ethics Committee?
1.9.3
Is the data entry system computerized or is it manual in a protocol book?
1.8.6
Do the volunteers' clinical files contain all the necessary data (name, age, sex, address, etc.)?
No.
Is there a database of volunteers?
1.9.2
1.8.7
National Health Surveillance Agency - ANVISA
Is there a record to control dispensed medications?
1.9.1
INF
R
I
I
I
I
I
Machine Translated by Google
1.8.5 N
Does the institution have a CEP?INF
Are all Protocols approved by the CEP before they start?
1.8.1N
Which. Items
1.8.2N
1.9. GOOD CLINICAL PRACTICES
1.9.5
1.8. DOCUMENTATION
This text does not replace the one(s) published in the Official Gazette.
Are/will volunteers' medical records be kept for a minimum period of five years?
1.9.4
Are the studies conducted in accordance with the protocol previously approved by the CEP?
1.8.4 INF
Is the researcher or any member of his team part of the CEP? If so, he abstains from judging his own
Ministry of Health - MS
1.8.3
Is there a clinical record of the study contemplating its particularities?
Are the study protocol and amendments submitted to the Research Ethics Committee?
1.9.3
Is the data entry system computerized or is it manual in a protocol book?
1.8.6
Do the volunteers' clinical files contain all the necessary data (name, age, sex, address, etc.)?
No.
Is there a database of volunteers?
1.9.2
1.8.7
National Health Surveillance Agency - ANVISA
Is there a record to control dispensed medications?
1.9.1
INF
R
I
I
I
I
I
Machine Translated by Google
Is there insurance for volunteers?
1.9.13 I
1.9.11 No
Are study drugs stored in an appropriate location with temperature and humidity control?
1.9.19 No
Is the Informed Consent Form dated and signed before any clinical procedure?
Are serious adverse events being reported to CEP and ANVISA?
No
1.9.18 R
researches?
1.9.16 No
Is all information generated during the clinical trial recorded and stored in order to ensure accurate reporting?
1.9.8
Are study drugs dispensed according to study guidelines?
1.9.12 No
This text does not replace the one(s) published in the Official Gazette.
1.9.14 No
Ministry of Health - MS
Is the confidentiality of volunteer records properly maintained?
1.9.6
1.9.10 N
INF Who is responsible for the process of obtaining the Free and Informed Consent Form?
Is there compensation for volunteers who participate in the studies?
Is there a medical referral procedure for volunteers in whom any disease was detected in pre-study exams?
1.9.7
Is the Research Ethics Committee registered with CONEP?
Is there a specific field for recording adverse events in clinical records?
1.9.9
1.9.17 No
Is there a procedure for monitoring the study by the sponsor?
National Health Surveillance Agency - ANVISA
Are studies conducted in accordance with national and international standards (ICH/GCP)?
1.9.15 N
I
I
Machine Translated by Google
1.9.13 I
1.9.11 No
Are study drugs stored in an appropriate location with temperature and humidity control?
1.9.19 No
Is the Informed Consent Form dated and signed before any clinical procedure?
Are serious adverse events being reported to CEP and ANVISA?
No
1.9.18 R
researches?
1.9.16 No
Is all information generated during the clinical trial recorded and stored in order to ensure accurate reporting?
1.9.8
Are study drugs dispensed according to study guidelines?
1.9.12 No
This text does not replace the one(s) published in the Official Gazette.
1.9.14 No
Ministry of Health - MS
Is the confidentiality of volunteer records properly maintained?
1.9.6
1.9.10 N
INF Who is responsible for the process of obtaining the Free and Informed Consent Form?
Is there compensation for volunteers who participate in the studies?
Is there a medical referral procedure for volunteers in whom any disease was detected in pre-study exams?
1.9.7
Is the Research Ethics Committee registered with CONEP?
Is there a specific field for recording adverse events in clinical records?
1.9.9
1.9.17 No
Is there a procedure for monitoring the study by the sponsor?
National Health Surveillance Agency - ANVISA
Are studies conducted in accordance with national and international standards (ICH/GCP)?
1.9.15 N
I
I
Machine Translated by Google
National Health Surveillance Agency - ANVISA
Does the team have the support of a medical body?
1.10.5 N
This text does not replace the one(s) published in the Official Gazette.
1.10.3 N
1.10.6 N
1.9.20 N
1.10.7 N
Is there a commitment to continued medical treatment in case of sequelae caused by adverse drug effects?
Does the team have the support of a nursing team?
1.10. STAFF
Is there an employee education and training program?
1.10.8 N
Which. Items
Are there records regarding the qualification and training of employees?
In the case of hospitalization of volunteers carried out in a non-hospital unit, does the doctor accompanying the study have a certification in
emergency care?
Does the principal investigator have experience in conducting clinical trials?
No.
Is the team uniformed?
1.10.9 R
1.10.1 N
Are the uniforms clean and in good condition?
Is the number of people in charge of collection sufficient for the number of hospitalized volunteers in each period?
Ministry of Health - MS
1.10.2 N
1.10.4 N
Machine Translated by Google
Does the team have the support of a medical body?
1.10.5 N
This text does not replace the one(s) published in the Official Gazette.
1.10.3 N
1.10.6 N
1.9.20 N
1.10.7 N
Is there a commitment to continued medical treatment in case of sequelae caused by adverse drug effects?
Does the team have the support of a nursing team?
1.10. STAFF
Is there an employee education and training program?
1.10.8 N
Which. Items
Are there records regarding the qualification and training of employees?
In the case of hospitalization of volunteers carried out in a non-hospital unit, does the doctor accompanying the study have a certification in
emergency care?
Does the principal investigator have experience in conducting clinical trials?
No.
Is the team uniformed?
1.10.9 R
1.10.1 N
Are the uniforms clean and in good condition?
Is the number of people in charge of collection sufficient for the number of hospitalized volunteers in each period?
Ministry of Health - MS
1.10.2 N
1.10.4 N
Machine Translated by Google
In the inclusion of the volunteer in the study, is the validity period of the exams of a maximum of three months respected?
At the time of hospitalization, is an inventory of the volunteers' belongings carried out in order to make sure that they are not bringing food, medicine and
others?
1.11.9 No
1.11.8
INF
1.11.4
11.1.13 I
Which. Items
INF
Do volunteers receive a kit containing a uniform and personal hygiene items for use during hospitalization?
1.11.12 INF Who monitors the intake/administration of medication by the volunteers?
1.11. PROCEDURES
Is the procedure for preparing and cleaning the beds for hospitalization adequate?
1.11.1
1.11.7
R
1.11.5
This text does not replace the one(s) published in the Official Gazette.
Are the volunteers hospitalized the day before they take the medication?
Ministry of Health - MS
1.11.3 N
What tests are carried out by volunteers?
Is there a pre-consultation immediately before the admission of volunteers?
INF How is the hospitalization procedure for volunteers?
1.11.6
Is the first blood collection performed before taking the drug?
What is the validity period of the tests performed by the volunteers?
No.
1.11.2
R
1.11.11 No
R
National Health Surveillance Agency - ANVISA
INF Who receives the volunteers at the place of hospitalization?
1.11.10 INF Who is in charge of receiving, keeping and storing the study drugs?
Machine Translated by Google
At the time of hospitalization, is an inventory of the volunteers' belongings carried out in order to make sure that they are not bringing food, medicine and
others?
1.11.9 No
1.11.8
INF
1.11.4
11.1.13 I
Which. Items
INF
Do volunteers receive a kit containing a uniform and personal hygiene items for use during hospitalization?
1.11.12 INF Who monitors the intake/administration of medication by the volunteers?
1.11. PROCEDURES
Is the procedure for preparing and cleaning the beds for hospitalization adequate?
1.11.1
1.11.7
R
1.11.5
This text does not replace the one(s) published in the Official Gazette.
Are the volunteers hospitalized the day before they take the medication?
Ministry of Health - MS
1.11.3 N
What tests are carried out by volunteers?
Is there a pre-consultation immediately before the admission of volunteers?
INF How is the hospitalization procedure for volunteers?
1.11.6
Is the first blood collection performed before taking the drug?
What is the validity period of the tests performed by the volunteers?
No.
1.11.2
R
1.11.11 No
R
National Health Surveillance Agency - ANVISA
INF Who receives the volunteers at the place of hospitalization?
1.11.10 INF Who is in charge of receiving, keeping and storing the study drugs?
Machine Translated by Google
Are post-study clinical and laboratory tests performed on volunteers?
1.11.16 No
1.12.1 N
Does it have SOP for sample identification and preparation?
1.11.18 INF
11.1.14 I
Is there temperature and blood pressure control of volunteers during hospitalization?
What is the volunteer discharge procedure?
Does it have SOP for recruiting and selecting volunteers?
Are collection times respected as established in the protocol?
1.12.4 N
1.11.20 No.
No.
Does it have SOP for storage and transport of samples?
1.11.15 INF
1.12.2 N
Ministry of Health - MS
1.11.22 INF
Is the menu prepared by a nutritionist according to the specifications of each study?
Does it have SOP for sample collection during hospitalization?
11.1.19 I
11.1.17 I
What is the established procedure for volunteer meals?
What type of material is used for collection (tubes, syringes, scalps, etc.)?
1.11.21 INF In the case of adverse events, what procedures are adopted?
Which. Items
This text does not replace the one(s) published in the Official Gazette.
1.12. STANDARD OPERATING PROCEDURES
National Health Surveillance Agency - ANVISA
Are the intercurrences, during the period of hospitalization of the volunteers, registered?
1.12.3 N
Machine Translated by Google
1.11.16 No
1.12.1 N
Does it have SOP for sample identification and preparation?
1.11.18 INF
11.1.14 I
Is there temperature and blood pressure control of volunteers during hospitalization?
What is the volunteer discharge procedure?
Does it have SOP for recruiting and selecting volunteers?
Are collection times respected as established in the protocol?
1.12.4 N
1.11.20 No.
No.
Does it have SOP for storage and transport of samples?
1.11.15 INF
1.12.2 N
Ministry of Health - MS
1.11.22 INF
Is the menu prepared by a nutritionist according to the specifications of each study?
Does it have SOP for sample collection during hospitalization?
11.1.19 I
11.1.17 I
What is the established procedure for volunteer meals?
What type of material is used for collection (tubes, syringes, scalps, etc.)?
1.11.21 INF In the case of adverse events, what procedures are adopted?
Which. Items
This text does not replace the one(s) published in the Official Gazette.
1.12. STANDARD OPERATING PROCEDURES
National Health Surveillance Agency - ANVISA
Are the intercurrences, during the period of hospitalization of the volunteers, registered?
1.12.3 N
Machine Translated by Google
National Health Surveillance Agency - ANVISA
1.12.8 N
1.13.3 N
1.13.6 INF
1.12.9 N
Are there criteria for defining the design of the experiment? Which?
This text does not replace the one(s) published in the Official Gazette.
Does it have SOP for hospitalization of volunteers?
1.13.4 N
Does it have SOP for emergency care of volunteers?
1.13. STUDY DESIGN
Is there a SOP for cleaning and preparing areas for the hospitalization of volunteers?
No.
Is the method of allocating volunteers to the drug intake sequence randomized? What procedure was adopted?
Does it have SOP for disposal of biological and non-biological materials?
Which. Items
1.13.5 I
1.12.5 N
Does it have SOP for receiving and controlling the drugs under study?
The person responsible for statistical analysis has qualifications in the area of statistics:
Software used:
1.12.6 N
1.13.1 No
1.13.2 INF Does the Center have assistance from a statistician?
Ministry of Health - MS
1.12.7 N
Does the responsible person participate in the planning of the study? (Decisions about experiment design, sample size, etc.).
Machine Translated by Google
1.12.8 N
1.13.3 N
1.13.6 INF
1.12.9 N
Are there criteria for defining the design of the experiment? Which?
This text does not replace the one(s) published in the Official Gazette.
Does it have SOP for hospitalization of volunteers?
1.13.4 N
Does it have SOP for emergency care of volunteers?
1.13. STUDY DESIGN
Is there a SOP for cleaning and preparing areas for the hospitalization of volunteers?
No.
Is the method of allocating volunteers to the drug intake sequence randomized? What procedure was adopted?
Does it have SOP for disposal of biological and non-biological materials?
Which. Items
1.13.5 I
1.12.5 N
Does it have SOP for receiving and controlling the drugs under study?
The person responsible for statistical analysis has qualifications in the area of statistics:
Software used:
1.12.6 N
1.13.1 No
1.13.2 INF Does the Center have assistance from a statistician?
Ministry of Health - MS
1.12.7 N
Does the responsible person participate in the planning of the study? (Decisions about experiment design, sample size, etc.).
Machine Translated by Google
National Health Surveillance Agency - ANVISA
1.14.3
How many data transcriptions are made since the end of the volunteers' analytical run?
1.14.10 INF
What is the procedure adopted in case of missing samples and/or problems in the chromatograms?
Is there a dated and signed record for checking the transcribed data?
1.14.11 INF
1.14. DATA PROCESSING
Are data transcriptions done manually or through a digital interface?
This text does not replace the one(s) published in the Official Gazette.
No.
Are occurrences from previous steps documented?
Which. Items
Does the person in charge receive information about occurrences from the previous steps?
What are the means for archiving the information generated in the process?
Is there SOP related to performing the statistical analysis and/or obtaining pharmacokinetic parameters?
1.14.4 INF
1.14.8 INF
INF How is the chromatogram data transcribed into worksheets?
Is there a procedure for criticizing the data obtained during collection times?
1.14.5 N
1.14.9 N
1.14.1 N
1.14.6 N
1.14.7
Ministry of Health - MS
1.14.2 N
INF How are pharmacokinetic parameters obtained?
Machine Translated by Google
1.14.3
How many data transcriptions are made since the end of the volunteers' analytical run?
1.14.10 INF
What is the procedure adopted in case of missing samples and/or problems in the chromatograms?
Is there a dated and signed record for checking the transcribed data?
1.14.11 INF
1.14. DATA PROCESSING
Are data transcriptions done manually or through a digital interface?
This text does not replace the one(s) published in the Official Gazette.
No.
Are occurrences from previous steps documented?
Which. Items
Does the person in charge receive information about occurrences from the previous steps?
What are the means for archiving the information generated in the process?
Is there SOP related to performing the statistical analysis and/or obtaining pharmacokinetic parameters?
1.14.4 INF
1.14.8 INF
INF How is the chromatogram data transcribed into worksheets?
Is there a procedure for criticizing the data obtained during collection times?
1.14.5 N
1.14.9 N
1.14.1 N
1.14.6 N
1.14.7
Ministry of Health - MS
1.14.2 N
INF How are pharmacokinetic parameters obtained?
Machine Translated by Google
I
National Health Surveillance Agency - ANVISA
Are the data transformed for modeling (ANOVA)?
1.15.8 INF
1.15.10 INF
1.15.2 INF
1.15.9 R
1.15.11 No
1.15. STATISTICAL ANALYSIS
Is the ANOVA based on the experimental design adopted in the evaluated study?
This text does not replace the one(s) published in the Official Gazette.
No.
1.15.3N
Which. Items
1.15.4 INF
Is the residual analysis performed after modeling?
Is preliminary (exploratory) data analysis performed before statistical modeling?
1.15.5N
Is any methodology used to verify the presence of an interaction effect between period and treatment (residual effect)?
What points were addressed in the preliminary analysis? Does it have a graphical presentation?
1.15.1 R
In the Analysis of Variance, are the effects of sequence (group), volunteers within the sequence, period and treatment considered?
What are the methods used to determine the Confidence Interval?
What are the criteria adopted for detecting outliers or outliers?
1.15.6 I
Are the software used in the statistical analysis appropriate?
Ministry of Health - MS
What steps are taken when detecting atypical observations?
1.15.7
Machine Translated by Google
National Health Surveillance Agency - ANVISA
Are the data transformed for modeling (ANOVA)?
1.15.8 INF
1.15.10 INF
1.15.2 INF
1.15.9 R
1.15.11 No
1.15. STATISTICAL ANALYSIS
Is the ANOVA based on the experimental design adopted in the evaluated study?
This text does not replace the one(s) published in the Official Gazette.
No.
1.15.3N
Which. Items
1.15.4 INF
Is the residual analysis performed after modeling?
Is preliminary (exploratory) data analysis performed before statistical modeling?
1.15.5N
Is any methodology used to verify the presence of an interaction effect between period and treatment (residual effect)?
What points were addressed in the preliminary analysis? Does it have a graphical presentation?
1.15.1 R
In the Analysis of Variance, are the effects of sequence (group), volunteers within the sequence, period and treatment considered?
What are the methods used to determine the Confidence Interval?
What are the criteria adopted for detecting outliers or outliers?
1.15.6 I
Are the software used in the statistical analysis appropriate?
Ministry of Health - MS
What steps are taken when detecting atypical observations?
1.15.7
Machine Translated by Google
National Health Surveillance Agency - ANVISA
2.1.3N
2.1.9 N
This text does not replace the one(s) published in the Official Gazette.
2.1.4 N
Is the lighting appropriate?
2. BIOANALYTICAL STAGE
No.
2.1. FACILITIES - GENERAL CONDITIONS
As for the external appearance, does the building(s) present (are) in good condition (free of cracks, infiltrations, etc.)?
Which. Items
Are the facilities constructed in such a way as to provide protection against the entry of insects and other animals?2.1.5N
2.1.1 INF
Are floors, walls and ceilings suitable for the activities carried out in the area?
Is the air conditioning adequate? Do they control and record temperature and humidity with a thermometer certified by INMETRO or an accredited laboratory
(RBC)?
2.1.2 INF
What is the physical area of the laboratory?
2.1.6 N
2.1.10 N
Are there sources of pollution or environmental contamination close to the company?
2.1.7 INF Is the area exclusive for the analysis of biological material?
Is access restricted to employees?
Ministry of Health - MS
Are the surroundings of the buildings clean?
2.1.8N
Machine Translated by Google
2.1.3N
2.1.9 N
This text does not replace the one(s) published in the Official Gazette.
2.1.4 N
Is the lighting appropriate?
2. BIOANALYTICAL STAGE
No.
2.1. FACILITIES - GENERAL CONDITIONS
As for the external appearance, does the building(s) present (are) in good condition (free of cracks, infiltrations, etc.)?
Which. Items
Are the facilities constructed in such a way as to provide protection against the entry of insects and other animals?2.1.5N
2.1.1 INF
Are floors, walls and ceilings suitable for the activities carried out in the area?
Is the air conditioning adequate? Do they control and record temperature and humidity with a thermometer certified by INMETRO or an accredited laboratory
(RBC)?
2.1.2 INF
What is the physical area of the laboratory?
2.1.6 N
2.1.10 N
Are there sources of pollution or environmental contamination close to the company?
2.1.7 INF Is the area exclusive for the analysis of biological material?
Is access restricted to employees?
Ministry of Health - MS
Are the surroundings of the buildings clean?
2.1.8N
Machine Translated by Google
Are there enough toilets (related to the area and number of employees)?
Page break
2.3.2 R
No.
2.2.1 R
2.2.5R
Which. Items
2.2.3 R
Is the positioning of freezers and refrigerators operational?
2.2. AUXILIARY FACILITIES
This text does not replace the one(s) published in the Official Gazette.
Is there an electricity generator for emergencies?
Is the physical space adequately distributed to carry out laboratory activities?2.3.1 R
2.2.6 INF
2.3.3 R
Ministry of Health - MS
2.2.4 N
Are there enough locker rooms (related to the area and number of employees)?
Is the circulation area for technicians good?
Are they in appropriate hygienic conditions?
2.3. ORGANIZATION OF THE LABORATORY ENVIRONMENT
Are they in appropriate hygienic conditions?
No.
2.2.2N
Is the positioning of the benches, in relation to the cabinets and equipment, operational?
Which. Items
National Health Surveillance Agency - ANVISA
Is access to toilets independent of the technical areas of the laboratory?
2.3.4 R
Machine Translated by Google
Page break
2.3.2 R
No.
2.2.1 R
2.2.5R
Which. Items
2.2.3 R
Is the positioning of freezers and refrigerators operational?
2.2. AUXILIARY FACILITIES
This text does not replace the one(s) published in the Official Gazette.
Is there an electricity generator for emergencies?
Is the physical space adequately distributed to carry out laboratory activities?2.3.1 R
2.2.6 INF
2.3.3 R
Ministry of Health - MS
2.2.4 N
Are there enough locker rooms (related to the area and number of employees)?
Is the circulation area for technicians good?
Are they in appropriate hygienic conditions?
2.3. ORGANIZATION OF THE LABORATORY ENVIRONMENT
Are they in appropriate hygienic conditions?
No.
2.2.2N
Is the positioning of the benches, in relation to the cabinets and equipment, operational?
Which. Items
National Health Surveillance Agency - ANVISA
Is access to toilets independent of the technical areas of the laboratory?
2.3.4 R
Machine Translated by Google
National Health Surveillance Agency - ANVISA
Were they clean at the time of the visit?
No.
2.5.3N
Are SOPs accessible to technicians?
Is there a Quality System, with designated personnel to ensure that responsibilities are being performed in accordance with the
principles of existing technical standards (GLP, ISO and OECD)?
2.5.4 INF Does the quality manager have other attributions in the laboratory's routine?
Is there a suitable place to place glassware for immediate use?
2.5.1 N
This text does not replace the one(s) published in the Official Gazette.
Is access to electricity easy?
Is there support for automatic pipettes?
2.3.5 R
2.4.1 N
Is the Quality Program disclosed to all employees?
2.3.6 R
2.4.2N
Does the laboratory have a quality manager?
No.
2.4. WORKBENCH ORGANIZATION
2.4.3N
2.5.2N
Which. Items
2.4.4R
2.5. GOOD LABORATORY PRACTICES
Ministry of Health - MS
Are countertops suitable (with regard to construction material)?
Which. Items
Machine Translated by Google
Were they clean at the time of the visit?
No.
2.5.3N
Are SOPs accessible to technicians?
Is there a Quality System, with designated personnel to ensure that responsibilities are being performed in accordance with the
principles of existing technical standards (GLP, ISO and OECD)?
2.5.4 INF Does the quality manager have other attributions in the laboratory's routine?
Is there a suitable place to place glassware for immediate use?
2.5.1 N
This text does not replace the one(s) published in the Official Gazette.
Is access to electricity easy?
Is there support for automatic pipettes?
2.3.5 R
2.4.1 N
Is the Quality Program disclosed to all employees?
2.3.6 R
2.4.2N
Does the laboratory have a quality manager?
No.
2.4. WORKBENCH ORGANIZATION
2.4.3N
2.5.2N
Which. Items
2.4.4R
2.5. GOOD LABORATORY PRACTICES
Ministry of Health - MS
Are countertops suitable (with regard to construction material)?
Which. Items
Machine Translated by Google
I
Is the team trained and oriented in order to guarantee the correct and complete execution of the defined processes and procedures?
Are new laboratory procedures only implemented after complete evaluation and approval by Quality Assurance?
Does the laboratory have an organization chart?
2.5.18 R
Is there a training program for laboratory employees?
2.5.10 N
This text does not replace the one(s) published in the Official Gazette.
Are there records of internal audits?
2.5.16 N
Is the Quality Manual easily accessible to the laboratory's technical staff?
Does quality management usually perform internal audits?
Does the Laboratory have records in the various sectors?
2.5.7N
2.5.14 I
2.5.19 No
2.5.11 No
Do you have Standard Operating Procedures?
Ministry of Health - MS
2.5.9 R
Does the person responsible for the Bioanalytical Stage have qualifications and experience in relation to the proposed activities?
2.5.17 No
2.5.5N
2.5.12 N
Does the Quality Manual include the individual attributions of the technical and managerial staff?
Are there records of the training and qualification of each employee?
Is the periodicity of the internal audit at least annual?
2.5.8
2.5.15 N
Is there a Quality Manual?
2.5.13 No
National Health Surveillance Agency - ANVISA
2.5.6N
Are SOPs appropriate and used by different sectors?
Machine Translated by Google
Is the team trained and oriented in order to guarantee the correct and complete execution of the defined processes and procedures?
Are new laboratory procedures only implemented after complete evaluation and approval by Quality Assurance?
Does the laboratory have an organization chart?
2.5.18 R
Is there a training program for laboratory employees?
2.5.10 N
This text does not replace the one(s) published in the Official Gazette.
Are there records of internal audits?
2.5.16 N
Is the Quality Manual easily accessible to the laboratory's technical staff?
Does quality management usually perform internal audits?
Does the Laboratory have records in the various sectors?
2.5.7N
2.5.14 I
2.5.19 No
2.5.11 No
Do you have Standard Operating Procedures?
Ministry of Health - MS
2.5.9 R
Does the person responsible for the Bioanalytical Stage have qualifications and experience in relation to the proposed activities?
2.5.17 No
2.5.5N
2.5.12 N
Does the Quality Manual include the individual attributions of the technical and managerial staff?
Are there records of the training and qualification of each employee?
Is the periodicity of the internal audit at least annual?
2.5.8
2.5.15 N
Is there a Quality Manual?
2.5.13 No
National Health Surveillance Agency - ANVISA
2.5.6N
Are SOPs appropriate and used by different sectors?
Machine Translated by Google
Do you have POP for sample storage?
Does it have SOP for use and maintenance of the water system?
2.6.8N
2.6.6N
2.6.1 N
Does it have SOP for use and maintenance of refrigeration systems?
2.6. STANDARD OPERATING PROCEDURES
Does it have SOP for drug stability studies in biological liquids?
2.6.4N
This text does not replace the one(s) published in the Official Gazette.
Do you have certification from any competent authority? Which entities?
2.6.11 No
Does it have SOP for use, maintenance and validation of chromatographic systems?
2.6.2N
2.6.7N
Does it have SOP for use and maintenance of scales?
2.6.9 N
Ministry of Health - MS
Does it have SOP for use and maintenance of the Peagameter?
Which. Items
2.6.5 N
Does it have SOP for sample identification?
Does it have SOP for the sequence of analytical runs?
Does it have SOP for transporting and receiving samples?
2.5.20 INF
Does it have SOP for validation of the analytical method?
2.6.3N
2.6.12 No
No.
National Health Surveillance Agency - ANVISA
Do you have POP for glassware washing?
2.6.10 N
Machine Translated by Google
Does it have SOP for use and maintenance of the water system?
2.6.8N
2.6.6N
2.6.1 N
Does it have SOP for use and maintenance of refrigeration systems?
2.6. STANDARD OPERATING PROCEDURES
Does it have SOP for drug stability studies in biological liquids?
2.6.4N
This text does not replace the one(s) published in the Official Gazette.
Do you have certification from any competent authority? Which entities?
2.6.11 No
Does it have SOP for use, maintenance and validation of chromatographic systems?
2.6.2N
2.6.7N
Does it have SOP for use and maintenance of scales?
2.6.9 N
Ministry of Health - MS
Does it have SOP for use and maintenance of the Peagameter?
Which. Items
2.6.5 N
Does it have SOP for sample identification?
Does it have SOP for the sequence of analytical runs?
Does it have SOP for transporting and receiving samples?
2.5.20 INF
Does it have SOP for validation of the analytical method?
2.6.3N
2.6.12 No
No.
National Health Surveillance Agency - ANVISA
Do you have POP for glassware washing?
2.6.10 N
Machine Translated by Google
Does it have SOP for the pharmacokinetic analysis of the data obtained?
Is the distribution of equipment/instruments arranged in a rational manner?
2.7.2 R
2.6.18 No
Does it have SOP establishing the criteria for sample reanalysis?
Is there a disinfection procedure for equipment?
Does it have POP for disinfection and disposal of biological and non-biological material?
What equipment is used for sample analysis?
2.6.16 No
This text does not replace the one(s) published in the Official Gazette.
2.6.13 No
2.7.5R
No.
2.6.14 No
2.6.19 No
Is the operation manual for each equipment available in the laboratory?2.7.3 R
Ministry of Health - MS
2.7.1 INF
Does it have SOP for evaluating the quality of the chromatograms?
2.6.17 No
Does it have SOP for storing study documentation?
Is there an electrical current stabilizer?
Do you have a SOP for preparing solutions and usage patterns?
Does it have SOP for use and maintenance of pipettes?
Which. Items
2.6.15 N
2.7.6N Is there no-break in the laboratory equipment?
National Health Surveillance Agency - ANVISA
2.7. EQUIPMENT
2.7.4R
Machine Translated by Google
Is the distribution of equipment/instruments arranged in a rational manner?
2.7.2 R
2.6.18 No
Does it have SOP establishing the criteria for sample reanalysis?
Is there a disinfection procedure for equipment?
Does it have POP for disinfection and disposal of biological and non-biological material?
What equipment is used for sample analysis?
2.6.16 No
This text does not replace the one(s) published in the Official Gazette.
2.6.13 No
2.7.5R
No.
2.6.14 No
2.6.19 No
Is the operation manual for each equipment available in the laboratory?2.7.3 R
Ministry of Health - MS
2.7.1 INF
Does it have SOP for evaluating the quality of the chromatograms?
2.6.17 No
Does it have SOP for storing study documentation?
Is there an electrical current stabilizer?
Do you have a SOP for preparing solutions and usage patterns?
Does it have SOP for use and maintenance of pipettes?
Which. Items
2.6.15 N
2.7.6N Is there no-break in the laboratory equipment?
National Health Surveillance Agency - ANVISA
2.7. EQUIPMENT
2.7.4R
Machine Translated by Google
What is the periodicity?2.8.2 INF
2.9. REFRIGERATION/AIR CONDITIONING SYSTEMS
2.8.9 INF
2.8.1
Are the columns used for more than one study?
Which. Items
Are chromatographic equipment installed properly?2.8.7N
This text does not replace the one(s) published in the Official Gazette.
2.8. CHROMATOGRAPHIC SYSTEMS
What is the temperature specification of the freezers?
Do you have a preventive and corrective maintenance program for this equipment?2.8.5 N
2.8.10 I Is the ideal temperature range respected for the operation of the equipment?
Which. Items
Ministry of Health - MS
Do you have a procedure for using, maintaining and storing chromatographic columns?
Is chromatography equipment certified/qualified periodically?
2.8.8N
What is the date of the last Certification/Qualification performed on the chromatography equipment?2.8.3 INF
No.
Is there a record for preventive and corrective maintenance?2.8.6N
No.
2.8.4N
National Health Surveillance Agency - ANVISA
Was the certification/qualification carried out by a qualified company?
2.9.1 INF
I
Machine Translated by Google
2.9. REFRIGERATION/AIR CONDITIONING SYSTEMS
2.8.9 INF
2.8.1
Are the columns used for more than one study?
Which. Items
Are chromatographic equipment installed properly?2.8.7N
This text does not replace the one(s) published in the Official Gazette.
2.8. CHROMATOGRAPHIC SYSTEMS
What is the temperature specification of the freezers?
Do you have a preventive and corrective maintenance program for this equipment?2.8.5 N
2.8.10 I Is the ideal temperature range respected for the operation of the equipment?
Which. Items
Ministry of Health - MS
Do you have a procedure for using, maintaining and storing chromatographic columns?
Is chromatography equipment certified/qualified periodically?
2.8.8N
What is the date of the last Certification/Qualification performed on the chromatography equipment?2.8.3 INF
No.
Is there a record for preventive and corrective maintenance?2.8.6N
No.
2.8.4N
National Health Surveillance Agency - ANVISA
Was the certification/qualification carried out by a qualified company?
2.9.1 INF
I
Machine Translated by Google
2.9.4N
Is there a record of the ambient temperature?
2.10.2 INF
What equipment is used for water purification?
2.9.2 N
2.9.9 No
Is the storage capacity of the freezers respected?
2.9.7 N
Which. ItemsNo.
Is there a record of the temperature of the freezers?
Is the water used subject to quality control?
2.9.6
2.9.10 R
Is there a deposit for the storage of purified water?
Are thermometers properly installed in refrigeration systems?
2.10.3 INF
Ministry of Health - MS
2.9.8N
Is there a record of the temperature of the refrigerators?
2.10.1 INF
2.9.5N
Do they have a hygrometer and room humidity record?
This text does not replace the one(s) published in the Official Gazette.
2.9.3 INF Do the freezers have identification?
I
2.10. WATER SYSTEM
2.10.4 N
Do you have a procedure for preventive and corrective maintenance of air conditioning equipment?
National Health Surveillance Agency - ANVISA
Are there alternative procedures in case of power outages, in order to preserve the contents of freezers and refrigerators?
If so, how long is the water stored?
Machine Translated by Google
Is there a record of the ambient temperature?
2.10.2 INF
What equipment is used for water purification?
2.9.2 N
2.9.9 No
Is the storage capacity of the freezers respected?
2.9.7 N
Which. ItemsNo.
Is there a record of the temperature of the freezers?
Is the water used subject to quality control?
2.9.6
2.9.10 R
Is there a deposit for the storage of purified water?
Are thermometers properly installed in refrigeration systems?
2.10.3 INF
Ministry of Health - MS
2.9.8N
Is there a record of the temperature of the refrigerators?
2.10.1 INF
2.9.5N
Do they have a hygrometer and room humidity record?
This text does not replace the one(s) published in the Official Gazette.
2.9.3 INF Do the freezers have identification?
I
2.10. WATER SYSTEM
2.10.4 N
Do you have a procedure for preventive and corrective maintenance of air conditioning equipment?
National Health Surveillance Agency - ANVISA
Are there alternative procedures in case of power outages, in order to preserve the contents of freezers and refrigerators?
If so, how long is the water stored?
Machine Translated by Google
2.10.8 No
No.
Which. Items
2.12. PEGAMETER
Is there a record for the maintenance of the water treatment system?
Is the calibration verification procedure carried out daily?
Is there a record for water quality control?
Is there a standard operating procedure for using an analytical balance?
2.11.5 INF
2.10.5 INF How often?
This text does not replace the one(s) published in the Official Gazette.
Is the scale certified by INMETRO or an accredited laboratory (Brazilian Calibration Network)?
2.11.3 N
No.
Is there a record of the calibrations performed?
Does the analytical laboratory have a pH meter?
Ministry of Health - MS
Is there a procedure for preventive and corrective maintenance of the analytical balance?
Is there a procedure for preventive and corrective maintenance of water purification equipment?
2.11.6 No
2.11. ANALYTICAL SCALE
2.11.1 No
2.10.7 R
2.10.6 N
Is the analytical balance installed according to the manufacturer's recommendations?
2.11.4 INF
2.11.2 N
National Health Surveillance Agency - ANVISA
Which. Items
2.12.1 I
Machine Translated by Google
No.
Which. Items
2.12. PEGAMETER
Is there a record for the maintenance of the water treatment system?
Is the calibration verification procedure carried out daily?
Is there a record for water quality control?
Is there a standard operating procedure for using an analytical balance?
2.11.5 INF
2.10.5 INF How often?
This text does not replace the one(s) published in the Official Gazette.
Is the scale certified by INMETRO or an accredited laboratory (Brazilian Calibration Network)?
2.11.3 N
No.
Is there a record of the calibrations performed?
Does the analytical laboratory have a pH meter?
Ministry of Health - MS
Is there a procedure for preventive and corrective maintenance of the analytical balance?
Is there a procedure for preventive and corrective maintenance of water purification equipment?
2.11.6 No
2.11. ANALYTICAL SCALE
2.11.1 No
2.10.7 R
2.10.6 N
Is the analytical balance installed according to the manufacturer's recommendations?
2.11.4 INF
2.11.2 N
National Health Surveillance Agency - ANVISA
Which. Items
2.12.1 I
Machine Translated by Google
National Health Surveillance Agency - ANVISA
2.12.5 N
Is there a maintenance record for the centrifuge?2.13.5 R
2.12.6 N
Is there a procedure for cleaning and decontaminating the centrifuge?2.13.6 N
Is there a procedure for using the pH meter?
No.
This text does not replace the one(s) published in the Official Gazette.
Is there a procedure for preventive and corrective maintenance of the pH meter?
2.13. CENTRIFUGE
Do you have a record of the pH meter calibrations?
Which. Items
2.13.2 R
Is the pH meter checked at least two pH points?
2.13.1 No
2.13.3 R
2.12.2 N
Are check buffers stored according to the manufacturer's recommendations?
Is the centrifuge installed according to the manufacturer's recommendations?
2.13.4 R
2.12.3 R
Does the centrifuge have a cooling system?
Is there a standard procedure for using the centrifuge?
Ministry of Health - MS
2.12.4 N
Is there a procedure for preventive and corrective maintenance of the centrifuge?
Machine Translated by Google
2.12.5 N
Is there a maintenance record for the centrifuge?2.13.5 R
2.12.6 N
Is there a procedure for cleaning and decontaminating the centrifuge?2.13.6 N
Is there a procedure for using the pH meter?
No.
This text does not replace the one(s) published in the Official Gazette.
Is there a procedure for preventive and corrective maintenance of the pH meter?
2.13. CENTRIFUGE
Do you have a record of the pH meter calibrations?
Which. Items
2.13.2 R
Is the pH meter checked at least two pH points?
2.13.1 No
2.13.3 R
2.12.2 N
Are check buffers stored according to the manufacturer's recommendations?
Is the centrifuge installed according to the manufacturer's recommendations?
2.13.4 R
2.12.3 R
Does the centrifuge have a cooling system?
Is there a standard procedure for using the centrifuge?
Ministry of Health - MS
2.12.4 N
Is there a procedure for preventive and corrective maintenance of the centrifuge?
Machine Translated by Google
Is volumetric glassware kept in a suitable place?
Do you have a procedure for cleaning and decontaminating pipettes/micropipettes?
R
This text does not replace the one(s) published in the Official Gazette.
2.14.3
Are tests carried out to verify the quality of the glassware washing process?
2.14.9
R
Which. Items
INF Is the periodicity of maintenance/calibration of the automatic pipettes at least annually?
2.14.2
No
2.14. GLASSWARE AND PIPETTES
No
Are automatic pipettes certified?
Are used tips discarded?
2.14.4
No
2.14.8
INF
Ministry of Health - MS
Is there a record of maintenance/calibration of automatic pipettes?
R
R
What type of vial material is used for the analytical run?
2.14.10 No
2.14.7
Is volumetric glassware certified by INMETRO or an accredited laboratory (Brazilian Calibration Network)?
No.
Do you have a procedure for using automatic pipettes?
2.14.1
2.14.6
2.14.11 I
National Health Surveillance Agency - ANVISA
Are used vials discarded?2.14.5
Machine Translated by Google
Do you have a procedure for cleaning and decontaminating pipettes/micropipettes?
R
This text does not replace the one(s) published in the Official Gazette.
2.14.3
Are tests carried out to verify the quality of the glassware washing process?
2.14.9
R
Which. Items
INF Is the periodicity of maintenance/calibration of the automatic pipettes at least annually?
2.14.2
No
2.14. GLASSWARE AND PIPETTES
No
Are automatic pipettes certified?
Are used tips discarded?
2.14.4
No
2.14.8
INF
Ministry of Health - MS
Is there a record of maintenance/calibration of automatic pipettes?
R
R
What type of vial material is used for the analytical run?
2.14.10 No
2.14.7
Is volumetric glassware certified by INMETRO or an accredited laboratory (Brazilian Calibration Network)?
No.
Do you have a procedure for using automatic pipettes?
2.14.1
2.14.6
2.14.11 I
National Health Surveillance Agency - ANVISA
Are used vials discarded?2.14.5
Machine Translated by Google
Does the laboratory have temperature and humidity records of storage locations?
2.16.1 INF
2.15.7 N
2.15.5 R
Are the reagents within their expiration date?
Which. Items
Do the reagents have lot number, concentration, impurities?
Do they use good labeling on reagent solutions prepared in the laboratory?
2.15.3N
This text does not replace the one(s) published in the Official Gazette.
2.15. REAGENTS
I
Does the laboratory have a fume hood for handling toxic reagents?
Is the water used in the preparation of the mobile phase type 1?
2.15.6 R
No.
2.16.2 INF
Ministry of Health - MS
2.16. MOBILE PHASE
2.15.2 I
2.15.4 N
Does the laboratory have inventory control?
What is the degree of purity of the solvents used to prepare the mobile phase?
Is storage of reagents done according to the manufacturer's recommendations?
2.15.1 I
2.15.8 N
Is the mobile phase prepared daily?2.16.4 R
What is the degree of purity of the additives for preparing the mobile phase (salts, acids, buffers, etc.)?
National Health Surveillance Agency - ANVISA
Are the reagents separated by classes (flammable, non-flammable, oxidizing, acids and bases)?
2.16.3
Machine Translated by Google
2.16.1 INF
2.15.7 N
2.15.5 R
Are the reagents within their expiration date?
Which. Items
Do the reagents have lot number, concentration, impurities?
Do they use good labeling on reagent solutions prepared in the laboratory?
2.15.3N
This text does not replace the one(s) published in the Official Gazette.
2.15. REAGENTS
I
Does the laboratory have a fume hood for handling toxic reagents?
Is the water used in the preparation of the mobile phase type 1?
2.15.6 R
No.
2.16.2 INF
Ministry of Health - MS
2.16. MOBILE PHASE
2.15.2 I
2.15.4 N
Does the laboratory have inventory control?
What is the degree of purity of the solvents used to prepare the mobile phase?
Is storage of reagents done according to the manufacturer's recommendations?
2.15.1 I
2.15.8 N
Is the mobile phase prepared daily?2.16.4 R
What is the degree of purity of the additives for preparing the mobile phase (salts, acids, buffers, etc.)?
National Health Surveillance Agency - ANVISA
Are the reagents separated by classes (flammable, non-flammable, oxidizing, acids and bases)?
2.16.3
Machine Translated by Google
Is mobile phase filtration carried out?
Do you use Pharmacopoeial Reference Chemical Substances?
2.17.4 N
2.17.2 I
2.16.9 INF
No.
2.16.7 INF
2.16.10 INF
Is there a procedure for discarding expired standards?
2.16.5 INF
This text does not replace the one(s) published in the Official Gazette.
What is the procedure for degassing the mobile phase?
Are reference standards stored in an appropriate location?
2.17.3 INF
Which. Items
2.17.5 R
Ministry of Health - MS
2.17. REFERENCE CHEMICAL SUBSTANCES
2.16.8 R
2.17.1 INF
What media are used for filtering the mobile phase?
Do the Working Chemical Substances (secondary standards) have an analysis report?
Is the pH of the mobile phase previously checked for analytical runs?
2.16.6 R
What is the cleaning procedure adopted for cleaning the mobile phase reservoir filter?
Is there a record of the stock control of the reference substances?
Are secondary standards provided by an institution independent of the contracting company?
National Health Surveillance Agency - ANVISA
Is the mobile phase degassing process carried out?
2.17.6 N
Machine Translated by Google
Do you use Pharmacopoeial Reference Chemical Substances?
2.17.4 N
2.17.2 I
2.16.9 INF
No.
2.16.7 INF
2.16.10 INF
Is there a procedure for discarding expired standards?
2.16.5 INF
This text does not replace the one(s) published in the Official Gazette.
What is the procedure for degassing the mobile phase?
Are reference standards stored in an appropriate location?
2.17.3 INF
Which. Items
2.17.5 R
Ministry of Health - MS
2.17. REFERENCE CHEMICAL SUBSTANCES
2.16.8 R
2.17.1 INF
What media are used for filtering the mobile phase?
Do the Working Chemical Substances (secondary standards) have an analysis report?
Is the pH of the mobile phase previously checked for analytical runs?
2.16.6 R
What is the cleaning procedure adopted for cleaning the mobile phase reservoir filter?
Is there a record of the stock control of the reference substances?
Are secondary standards provided by an institution independent of the contracting company?
National Health Surveillance Agency - ANVISA
Is the mobile phase degassing process carried out?
2.17.6 N
Machine Translated by Google
National Health Surveillance Agency - ANVISA
2.18.4 I
2.19. EXTERNAL TRANSPORTATION OF SAMPLES
2.19.2 INF
2.18.5 I
Which. Items
This text does not replace the one(s) published in the Official Gazette.
2.18. SAMPLES
2.19.1 INF
2.18.1 N
Do the samples have adequate labeling containing all the data necessary for their identification?
Is there a record of receipt of samples?
Are biological samples aliquoted? What procedure was adopted?
Is there external transport of biological samples?
Does the laboratory have a checklist for receiving samples (temperature history, sample identification and data, package condition, etc.)?
In the case of reanalysis of samples, are they duly justified and recorded?
Are biological samples pre-processed at their place of origin?
2.18.3 INF
2.18.2 R
In the case of loss of samples, are they duly justified and recorded?
No.
What is the storage temperature of biological samples?
2.18.6 INF
2.18.7 N
Ministry of Health - MS
Are biological samples properly stored in freezers? Do you perform temperature control using thermometers certified by INMETRO or an accredited
laboratory (RBC)?
2.18.8 N
Machine Translated by Google
2.18.4 I
2.19. EXTERNAL TRANSPORTATION OF SAMPLES
2.19.2 INF
2.18.5 I
Which. Items
This text does not replace the one(s) published in the Official Gazette.
2.18. SAMPLES
2.19.1 INF
2.18.1 N
Do the samples have adequate labeling containing all the data necessary for their identification?
Is there a record of receipt of samples?
Are biological samples aliquoted? What procedure was adopted?
Is there external transport of biological samples?
Does the laboratory have a checklist for receiving samples (temperature history, sample identification and data, package condition, etc.)?
In the case of reanalysis of samples, are they duly justified and recorded?
Are biological samples pre-processed at their place of origin?
2.18.3 INF
2.18.2 R
In the case of loss of samples, are they duly justified and recorded?
No.
What is the storage temperature of biological samples?
2.18.6 INF
2.18.7 N
Ministry of Health - MS
Are biological samples properly stored in freezers? Do you perform temperature control using thermometers certified by INMETRO or an accredited
laboratory (RBC)?
2.18.8 N
Machine Translated by Google
National Health Surveillance Agency - ANVISA
2.19.6 INF
No.
Are analyzes performed to determine the limit of quantification?
2.19.7 INF
2.21.1 I
This text does not replace the one(s) published in the Official Gazette.
Is there prior knowledge of the times and dates of road or air dispatch?
Does the laboratory have complete records of validations?
Are thermal boxes with suitable refrigeration material used for the time of transport of biological samples?
2.20. INTERNAL SAMPLE TRANSPORT
Do biological samples come with a temperature recording device during the journey?
No.
Are accuracy and precision studies performed within acceptable limits?
What is the means used for the external transport of samples?
Which. Items
2.21.2 I
2.19.3 N
What is the average duration of the external transport of samples?
2.20.1 INF How is the internal transport of samples done?
2.21.3 N
2.19.4 N
2.21. VALIDATION OF ANALYTICAL METHODS
NAME OF THE AUDITED STUDY:
Ministry of Health - MS
2.19.5 R
Which. Items
Machine Translated by Google
2.19.6 INF
No.
Are analyzes performed to determine the limit of quantification?
2.19.7 INF
2.21.1 I
This text does not replace the one(s) published in the Official Gazette.
Is there prior knowledge of the times and dates of road or air dispatch?
Does the laboratory have complete records of validations?
Are thermal boxes with suitable refrigeration material used for the time of transport of biological samples?
2.20. INTERNAL SAMPLE TRANSPORT
Do biological samples come with a temperature recording device during the journey?
No.
Are accuracy and precision studies performed within acceptable limits?
What is the means used for the external transport of samples?
Which. Items
2.21.2 I
2.19.3 N
What is the average duration of the external transport of samples?
2.20.1 INF How is the internal transport of samples done?
2.21.3 N
2.19.4 N
2.21. VALIDATION OF ANALYTICAL METHODS
NAME OF THE AUDITED STUDY:
Ministry of Health - MS
2.19.5 R
Which. Items
Machine Translated by Google
Are short-term stability studies performed?
2.23. BIOSECURITY - COLLECTIVE PROTECTION
Is there a disposal treatment program?
2.23.3 R
2.22.1 I
2.22.4 I
2.22. STABILITY
Is a drug stability study carried out in stock solutions?
Is the technical staff of the laboratory periodically submitted to health examinations?
Is the recovery level of the method determined?
Do stability studies include the period between collection and analysis of the last study sample (long-term stability)?
2.23.1 R
Is there an employee vaccination program?
2.22.5 I
2.23.4 N
Ministry of Health - MS
A post-processing stability study is carried out.
Which. Items
2.23.2 R
No.
Which. Items
Are stability studies carried out in sample freezing and thawing cycles?
2.21.4 N
2.22.3 I
Is there a Biosafety Commission?
No.
National Health Surveillance Agency - ANVISA
2.22.2 I
This text does not replace the one(s) published in the Official Gazette.
Machine Translated by Google
2.23. BIOSECURITY - COLLECTIVE PROTECTION
Is there a disposal treatment program?
2.23.3 R
2.22.1 I
2.22.4 I
2.22. STABILITY
Is a drug stability study carried out in stock solutions?
Is the technical staff of the laboratory periodically submitted to health examinations?
Is the recovery level of the method determined?
Do stability studies include the period between collection and analysis of the last study sample (long-term stability)?
2.23.1 R
Is there an employee vaccination program?
2.22.5 I
2.23.4 N
Ministry of Health - MS
A post-processing stability study is carried out.
Which. Items
2.23.2 R
No.
Which. Items
Are stability studies carried out in sample freezing and thawing cycles?
2.21.4 N
2.22.3 I
Is there a Biosafety Commission?
No.
National Health Surveillance Agency - ANVISA
2.22.2 I
This text does not replace the one(s) published in the Official Gazette.
Machine Translated by Google
Is there educational signage to prevent the risk?2.23.11 R
Do employees wear long lab coats with long sleeves?
2.24.1 No
Are fire extinguishers, sand/granulated absorbent available?2.23.9 No
Are suitable containers used for the disposal of broken glassware?2.23.7 R
Which. Items
This text does not replace the one(s) published in the Official Gazette.
Do you decontaminate the biological waste produced during laboratory activities?
2.24.4 N
2.23.5 N
2.24. PERSONAL PROTECTION
2.24.2 N
2.23.10 No
Do employees wear disposable gloves?
Ministry of Health - MS
2.23.8 N Do you have an emergency shower and eye wash?
Does the laboratory provide and guide employees to use PPE (Personal Protective Equipment)?
Is there information on how to act in an emergency, such as: telephone numbers for hospitals, emergency rooms and fire departments?2.23.12 No
Is accident prevention and reporting carried out?
Are care taken for the packaging and final disposal of chemical waste?2.23.6 N
No.
Do employees wear goggles or face shield?
2.23.13 R
National Health Surveillance Agency - ANVISA
Are boxes with first aid materials available in case of accidents?
2.24.3N
Machine Translated by Google
Do employees wear long lab coats with long sleeves?
2.24.1 No
Are fire extinguishers, sand/granulated absorbent available?2.23.9 No
Are suitable containers used for the disposal of broken glassware?2.23.7 R
Which. Items
This text does not replace the one(s) published in the Official Gazette.
Do you decontaminate the biological waste produced during laboratory activities?
2.24.4 N
2.23.5 N
2.24. PERSONAL PROTECTION
2.24.2 N
2.23.10 No
Do employees wear disposable gloves?
Ministry of Health - MS
2.23.8 N Do you have an emergency shower and eye wash?
Does the laboratory provide and guide employees to use PPE (Personal Protective Equipment)?
Is there information on how to act in an emergency, such as: telephone numbers for hospitals, emergency rooms and fire departments?2.23.12 No
Is accident prevention and reporting carried out?
Are care taken for the packaging and final disposal of chemical waste?2.23.6 N
No.
Do employees wear goggles or face shield?
2.23.13 R
National Health Surveillance Agency - ANVISA
Are boxes with first aid materials available in case of accidents?
2.24.3N
Machine Translated by Google
National Health Surveillance Agency - ANVISA
2.25. DOCUMENTATION
This text does not replace the one(s) published in the Official Gazette.
No.
Do employees wear masks?
Do employees wear closed shoes or protective shoes?
Which. Items
Do employees wear clothing that protects their legs (long pants)?
What are the archiving means for study chromatograms and other documents?
Is the washing of uniforms used by employees the responsibility of the laboratory?
2.25.1 INF
2.24.6 N
2.24.5 R
2.25.2 R
2.24.7 N
Is access to study documentation facilitated?
Is the study documentation archived for a minimum period of 10 years?
Ministry of Health - MS
2.24.8 R
2.25.3 I
Machine Translated by Google
2.25. DOCUMENTATION
This text does not replace the one(s) published in the Official Gazette.
No.
Do employees wear masks?
Do employees wear closed shoes or protective shoes?
Which. Items
Do employees wear clothing that protects their legs (long pants)?
What are the archiving means for study chromatograms and other documents?
Is the washing of uniforms used by employees the responsibility of the laboratory?
2.25.1 INF
2.24.6 N
2.24.5 R
2.25.2 R
2.24.7 N
Is access to study documentation facilitated?
Is the study documentation archived for a minimum period of 10 years?
Ministry of Health - MS
2.24.8 R
2.25.3 I
Machine Translated by Google
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