Quality Management System in of pharma .pdf

All information about QMS and there Branches.

1. QUALITY MANAGEMENT SYSTEM

2. CONTENTS
➢INTRODUCTION OF QMS
➢CHANGE CONTROL
➢INCIDENT/DEVIATIONS
➢LABORATORY INCIDENTS
➢CAPAs
➢APQR
➢VALIDATION
➢MARKET COMPLAINTS
➢CONCLUSION

3. INTRODUCTION
Definition of Quality Management System:
QMS is set of interconnected elements (Quality Policy, procedures,
Manual, Work instructions, Records) that direct and control the Organization in
consistently meeting the customer requirements and enhance the customer
satisfaction.
Objective of Quality Management System:
➢Simplify the organization structure, Improve the process, Improve the
productivity, Increase the customer satisfaction and Improve the
documentation
➢Consistent in products Quality, Reduce the cost and wastes. To avoid the
recalls and return goods and Improve the compliance

4. CHANGE CONTROL
Definition of change control:
The modification of any equipment, Process, product, any
software or whatever its called as change and the system is required to
control or maintain the quality by properly documentation, validation and
approval is called as change control.
These are two types:
1.Permanent change control
2.Temporary change control
1.Permanent change control:
When we are making any permanent changes in some operation
procedure manufacturing facility, system etc…for forever. This type of
changes are handled through permanent change control
Example: When we will upgrade system by installing auto system in place of
manually operator system, such type changes are called permanent change.

5. 2.Temporary change control:
When we are making any changes in some operation, procedure
manufacturing facility system etc., for certain period of time after that it will
restored to its original system. This type of changes are handled through
temporary change control.
Example: In powder processing area pulverizer is not working so in place of
pulverizer we are temporarily using multi mill till pulverizer gets in working
condition.
Objects of change control:
➢Change control in the pharmaceutical industry used to modify any process of
pharmaceutical SOP.
➢It ensures that change does not effect the outputs intent and fullfills all the
quality principle associated with specific with product or process
➢Change control aims to minimize risks and ensure that any modifications
made within the pharmaceutical manufacturing process do not negatively
impact product quality, safety, or efficacy
➢Improved productivity. ...
➢Decreased cost of changes

6. Functional group involved in Change Control

7. DEVIATION/INCIDENT
Definition of deviation/incident:
Departure of an activity from an approved instructions or established
standards.
➢Both deviation and Incidents are Synonyms.
Deviations are categorized into two types:
1.Planned deviation:
Now, Handling through temporary change control.
2.Unplanned deviation: (Non-conformances)
Which are handled through Incident procedures.
Incidents may be categorized into three types:
1.Critical incidents
2.Major incidents
3.Minor incidents
➢QA shall categorize the incident.

8. 1.Critical incidents:
Adverse impact to product quality, patient safety and integrity.
Examples:
oProduct mix up
oPhysical contamination
oChemical contamination
2.Major incidents:
Potential impact to product Quality/process and or GMP system
Examples:
oExpired or rejected API component used
oProduction started without line clearence
oOut of yield range
oUnusual or strong odor

9. 3.Minor incidents:
An incident which is neither critical nor major from above definitions.
No impact to product quality or GMP system.
Example:
oSkip of FEFO principle (first expired-first out) in raw material handling.
Correction:
Correction is an action to bring the impact under control for an incident.
Corrective action:
Action to eliminate the cause of an incident. Corrective action is taken
to prevent recurrence of incident.
Preventive action:
Action to eliminate the cause of a potential source for incident.
preventive action is taken to prevent occurrence.

10. ➢User department is responsible for writing the CAPA in deviation/incident
report.
➢All incidents shall be reported within 24 hours of occurrence
➢Incident report numbering system shall be
➢IR indicates Incident report
AAA-unit code
YY indicates year
XXX Product/Department code
ZZZZ Indicates Serial number
➢Investigation shall be done.
Timelines:
➢All minor incidents shou be closed within 15 days from date of reporting.
➢Major Incidents shall be closed within 30days from date of reporting.
➢Critical incidents shall be, immediate action in 7days from date of
identification closed within 30 days.

11. LABORATORY INCIDENT
Definition of laboratory incident:
Unplanned in the form of non compliance from the designed systems
or procedures at any stage of QC activities
➢LABORATORY INCIDENTS ARE OCCURS DUE TO MAINLY TWO REASONS EITHER
MANUAL ERRORS OR SYSTAMATIC ERRORS/INSTRUMENTAL ERRORS:
oDue to system failure
oPower failure
oInstrumental errors
oManual errors, etc.,

12. ➢LABORATORY INCIDENT OCCURS IT SHOULD BE INVESTIGATED AND DOCUMENTED:
oIdentification and recording
oInvestigation for root cause
oRemedial actions: CAPA, If required
oLaboratory incident closure
Laboratory incidents are four types:
1.Minor incidents
2.Major incidents
3.Critical incidents
4.Numbering system

13. 1.Minor incidents:
Minor does not affect any quality attributes
oDoors are not closed properly
oLights are not working in testing area
oSoftware failures – data not acquired during analysis
oColumn efficiency is poor during analysis
2.Major incidents:
Affect any quality attributes
oEnvironmental condition out of limit during testing
oOperating instructions are not followed
oIn-process control limits not achieved
oCalculation error after final reporting
oYields are not meeting specified limits

14. 3.Critical incident:
Affects critical quality attributes, a critical test parameter which
impact to patient like life threatening situation.
oUsage of expired are rejected materials for analysis
oMajor and critical incident shall be investigated as per” investigations” SOP
oMinor incidents in QC are handled through LIR SOP
4.Number system:
Incident, selection code, year, serial number Ex: IRIP/23/001
oLaboratory incident report shall be filed in QA
oA copy of small be kept with affected document, e.g. Calibration record
analytical report etc.,

15. CAPA
(CORRETIVE ACTION AND PREVENTIVE ACTION)
Definition of CAPA:
CAPA is a quality assurance system, which addresses quality events,
which may occur or could be anticipated to occur during healthcare products
manufacturing.
➢An improvement tool used within good manufacturing practice (GMP)
principles and various ISO standards
➢Aims to prevent issue recurrence (corrective action) or to prevent issue
occurrence (preventative action)
➢CAPA is the core of continuous improvement systems

16. Key CAPA definitions:
Corrective Action:
Action to eliminate the causes of a detected nonconformity or other
undesirable situation. The corrective action should eliminate the recurrence of
the issue.
Preventative Action:
Action to eliminate the causes of a potential nonconformity or other
undesirable potential situation. Preventative action should prevent the
occurrence of the potential issue.

17. Correction, corrective action and preventive action:

18. CAPA Work flow:

19. Quality systems centre-CAPA:

20. Tools for identifying causes:

21. APQR
(ANNUAL PRODUCT QUALITY REVIEW)
Definition of APQR:
APQR is an effective quality improvement tool to enhance the
consistency of the process and overall quality of product.
➢It is a regular periodic quality review of all products manufactured in the facility
to verify, that the process is consistency.
Frequency of APQR:
Shall be done after completion of 12 months PQR shall be prepared and
evaluated for all the products of all the batches of all the processes, separately.

22. Contents of APQR:
➢Number of batches produced
➢Number of batches dispatched
➢Stability data
➢Validation
➢Qualification
➢Training
➢Deviations
➢Complaint’s, etc.,

23. Contents of APQR (But Not Limited to):
➢Review of Product and Process related validation activities.
➢Review of change controls & deviations and their status ie open or close.
➢Status of corrective and preventive action (CAPA) releted to process and drug
products.
➢Review of Out Of Specifications(OOS),Out Of Trend(OOT) result if any
➢Review of product complaints number of complaints received and open and
closed status etc
➢Product recall and filed alerts.
➢Review Returned finished GoodsReview of Elemental impurities
➢Review of previous "Annual product Quality Review if any
➢Conclusion shall contains the observations and the finding which are obtained
during review of APQR

24. ➢The data of In process parameters obtained from manufacturing and packing
Analytical Parameters of
oBlend
oFilled capsule
oCompressed tablets
oCoated tablets
oFinish Products
oRaw materials packing materials and
➢Stability data shall be calculated for minimum, maximum, average and cpk
values.

25. VALIDATION
Definition of Validation:
Validation is a documented evidence to demonstrate that all the
process, system, utility or facility are designed in such a way that they produce the
same result on repeated usage.
Some important validations in pharmaceutical industry:
1.Process validation
2.Cleaning validation
3.Method validation
4.Computer validation
➢These four validations are mostly used in pharmaceutical industries.

26. 1.Process validation:
Process validation is an established documented program which
gives high degree of assurance that specific process will consistently produce a
product meeting its predetermined specifications and quality attributes.
Types of process validation:
a) Prospective validation
b) Concurrent validation
Prospective validation:
Prospective validation is establishing documented evidence that a
system performs as it is intended based on pre-planned protocol.
➢Minimum three batches should be selected/based on the risk assessment.

27. Concurrent validation:
We can start with one/two batches also.
➢The word concurrent can be remembered by a simple word current, which
means this type of validation is performed on current production batches.
➢Concurrent validation shall be done in case of
oShortages of raw materials
oLack of orders

28. 2.Cleaning validation:
Cleaning validation is a documented evidence which provides high
degree of assurance that an approved cleaning procedure will provide equipment
that is suitable for processing of pharmaceutical products.
Types of cleaning validation: In this cleaning validation two types are there
1.Batch to batch cleaning
2.Production change over
➢These two cleaning validation types depends on two samples
Rinse sample
Swab sample

29. 3.Analytical method validation:
Method validation is the process of demonstrating that analytical
procedures are suitable for their intended use and that they support the
identity, strength, quality, purity and potency of the drug substance and drug
product.
4.Computer validation:
Computer validation is a process used to ensure that a computer-
based system will produce information or data that meet a set of defined
requirements.
In what cases is validation done?
oNew product
oNew process
oNew equipment
oScale up
oScale down
oBlock change
oRaw material change, etc.,

30. Importance of Validation:
➢Validation ensures the product quality.
➢Reduces the chances of non-compliance.
➢Reduces the chances of product recall.
➢Data of validation acts as a proof in making decisions.
➢Meet regulatory requirement.
➢During inspection validation data gives assurance to the inspecting bodies.

31. MARKET COMPLAINTS
Definition of Market Complaints:
Any written, electronic oral communication that alleges deficiencies
related to identity Quality Safety effectiveness or performance of a device.
Quality defect:
Qualitative and quantitative composition of the product is lacking
The Therapeutic efficacy.
Adverse Drug Reaction:
Is a response to noxious a medicinal product which and unintended.

32. Types of Complaints: Complaints are classified into three types
1.Critical complaints
2.Major complaints
3.Minor complaints
1.Critical complaints:
Complaints which can be life Threatening and require immediate action.
oAdverse drug reaction
oAdverse drug events
oMajor health hazards
oProduct Stability problems
2.Major complaints:
Which can be put the patient at risk but are not life threatening.
oProblem with chemical and physical contamination of the product
oProblem with primary packing
oAny labeling
oNon-compliance to specifications

33. Minor complaints:
Which may lead to minor risk to the patient.
oProblem related to coding of the batch
oQuality Shortage
oSecondary packaging materials prodder
oComplaint numbering system.

34. CONCLUSION
➢The total quality management drives customer satisfaction by ensuring that
consistent delivery of high-quality product or services is in place.
➢For acheiving result beyond customer expectations, you need to implement an
effective quality management process for your testing team.
➢A QMS (Quality management system) can help startups products deliver consistent,
high quality products or services that meet or exceed customer expectations,
which can help build customer trust and loyalty.