GMP TRAINING ON PERSONNEL TRAINING AND ENTRY IN CLEANRROM.ppt

GMP TRAINING ON PERSONNEL TRAINING AND ENTRY IN CLEANRROM.ppt

1. Personnel training and entry in
Cleanroom
Presented by:
D
r/Norhan Saif
D
r/Norhan Saif
B
1 IPC Manager

2. Personnel Are The Major Source: Personnel Are The Major Source:
 Microbial Contamination
 Particles and Particles
 All personnel should be aware of GMP
 Must receive training in GMP:
 Initial training.
 Continuing training.
 Including hygiene standards.
 Motivated to
 Support The Establishment.
 Maintain High-Quality Standards.

3.  USP 35, 2011 highlights the importance of aseptic operator training:USP 35, 2011 highlights the importance of aseptic operator training:
 Is equally for personnel for microbiological monitoring, where contamination could Is equally for personnel for microbiological monitoring, where contamination could
occur due to inappropriate sampling techniques.occur due to inappropriate sampling techniques.
Education, Garments and behavior are important factors:Education, Garments and behavior are important factors:
 ISO 14644-5, 1998 states:ISO 14644-5, 1998 states:
 Only essential personnel should enter the cleanroom. Only essential personnel should enter the cleanroom.
 Only trained people should be allowed to work in the room. Only trained people should be allowed to work in the room.
 Visitors and maintenance people should be allowed into the room by permission Visitors and maintenance people should be allowed into the room by permission
and under supervision.and under supervision.
 USP 35, 2011 concerns the personnel hygiene:USP 35, 2011 concerns the personnel hygiene:
 Hand washing and disinfection procedures.Hand washing and disinfection procedures.
 Gowning procedures.Gowning procedures.
 Aseptic techniques.Aseptic techniques.
 Emergency procedures to protect sterility (Loss of HVAC, Loss of Power). Emergency procedures to protect sterility (Loss of HVAC, Loss of Power).

4. Prevent unauthorized access toPrevent unauthorized access to

Production areas.Production areas.

Storage areas.Storage areas.

Quality control.Quality control.

5. Key Personnel (1)Key Personnel (1)

Key personnel (full-time) positions include:Key personnel (full-time) positions include:

Authorized person.Authorized person.

Head of Production.Head of Production.

Head of Quality Control.Head of Quality Control.

May delegate functions – not responsibility.May delegate functions – not responsibility.

Heads of Production and QC should be independent of each other.Heads of Production and QC should be independent of each other.

6. Key Personnel (2)Key Personnel (2)

Should posses scientific education :Should posses scientific education :

Chemistry or Biochemistry.Chemistry or Biochemistry.

Chemical Engineering.Chemical Engineering.

Microbiology.Microbiology.

Pharmaceutical Sciences and Technology.Pharmaceutical Sciences and Technology.

Pharmacology and Toxicology.Pharmacology and Toxicology.

7. Key Personnel (3)Key Personnel (3)

Should posses practical experience:Should posses practical experience:

Manufacture and Quality assurance.Manufacture and Quality assurance.

Preparatory period under professional guidance.Preparatory period under professional guidance.

Education and experience to take difficult decisions in an independent, Education and experience to take difficult decisions in an independent,
professional and scientific way:professional and scientific way:

Resolve the problems encountered in manufacturing & QC.Resolve the problems encountered in manufacturing & QC.

8. Head of Production Head of Production

Product production & storage to appropriate documentation.Product production & storage to appropriate documentation.

Approval and implementation of production instructions.Approval and implementation of production instructions.

in-process QC and ensure strict implementation.in-process QC and ensure strict implementation.

Ensures that production records are evaluated and signed by designated Ensures that production records are evaluated and signed by designated
person.person.

Checks maintenance: production dept , premises and equipment.Checks maintenance: production dept , premises and equipment.

Ensures process validation and calibration performed, recorded.Ensures process validation and calibration performed, recorded.

Ensures initial and continuous training of production personnel.Ensures initial and continuous training of production personnel.

9. Head of Quality Control Head of Quality Control

Approval or rejection of materials , in acc! with specifications.Approval or rejection of materials , in acc! with specifications.

Evaluation of batch records.Evaluation of batch records.

Carrying out of necessary testing.Carrying out of necessary testing.

Approval of QC procedures, e.g. sampling & testing; specifications.Approval of QC procedures, e.g. sampling & testing; specifications.

Approval and monitoring of all contract analysis.Approval and monitoring of all contract analysis.

Checks maintenance of QC dept, premises and equipment.Checks maintenance of QC dept, premises and equipment.

Ensures validation (including analytical procedure validation) and calibration of Ensures validation (including analytical procedure validation) and calibration of
control equipment.control equipment.

Ensures initial and continuous training of QC personnel.Ensures initial and continuous training of QC personnel.

10. Authorized person: QAAuthorized person: QA

Compliance with technical and regulatory requirements.Compliance with technical and regulatory requirements.

Approval of the release of finished product for sale.Approval of the release of finished product for sale.

Establishment and implementation of quality system.Establishment and implementation of quality system.

Development of Development of Quality ManualQuality Manual..

Supervision of self-inspections and quality audits.Supervision of self-inspections and quality audits.

Oversight of the QC department.Oversight of the QC department.

Participation in external audits and vendor audits.Participation in external audits and vendor audits.

Participation in validation programmes.Participation in validation programmes.

May delegate approval of release of product through approved procedure.May delegate approval of release of product through approved procedure.
Production
Quality
Control

11. An official An official document produced by a by a business that details how its that details how its
quality management system operates. A . A typical quality manual will include the manual will include the
company's quality policy and and goals, as well as a , as well as a detailed description of its of its
quality control system that might include system that might include staff roles and relationships, and relationships,
procedures, systems and any other resources that relate to producing high procedures, systems and any other resources that relate to producing high
quality goods or services.quality goods or services.
What is Quality manualWhat is Quality manual??

12. Heads of Production and Quality Control share some responsibilities related to Heads of Production and Quality Control share some responsibilities related to
quality:quality:

Authorization of written procedures (SOPs).Authorization of written procedures (SOPs).

Monitoring and control of manufacturing environment.Monitoring and control of manufacturing environment.

Plant hygiene.Plant hygiene.

Process validation and calibration.Process validation and calibration.

Training, including application and principles of QA.Training, including application and principles of QA.

Approval and monitoring of suppliers and contract acceptors.Approval and monitoring of suppliers and contract acceptors.
Shared Responsibilities (1)Shared Responsibilities (1)

13. Shared Responsibilities (2)Shared Responsibilities (2)

Monitoring of storage conditions for materials and products.Monitoring of storage conditions for materials and products.

Performing and evaluating in-process controls.Performing and evaluating in-process controls.

Retention of records.Retention of records.

Monitoring compliance with GMP.Monitoring compliance with GMP.

Inspection, investigation, and taking of samples to monitor factors which Inspection, investigation, and taking of samples to monitor factors which
may affect quality.may affect quality.

14. Techniques Maintain Sterility of Sterile ItemsTechniques Maintain Sterility of Sterile Items: :

Contact sterile materials only with sterile instruments.Contact sterile materials only with sterile instruments.

Minimize the number of personnel.Minimize the number of personnel.

Move slowly Move slowly

Keep the entire body out of the path of unidirectional airflowKeep the entire body out of the path of unidirectional airflow

Maintain proper gown control.Maintain proper gown control.

15. What is meant by GowningWhat is meant by Gowning? ?
The use of articles of apparel and accessories specified for use by The use of articles of apparel and accessories specified for use by
personnel to protect the personnel to protect the workingworking areaarea from human and other foreign from human and other foreign
particles. particles.

16. 1. Area Classification.1. Area Classification.
2. The Process. 2. The Process.
It should be worn in a such way as to protect the product It should be worn in a such way as to protect the product
from contamination.from contamination.
For Proper Gowning We Need First To KnowFor Proper Gowning We Need First To Know::

17. Sterile Area Sterile Area
(Class A & B)(Class A & B)
(Class C)(Class C)
(Class E)(Class E)
(Class D)(Class D)

18. Class AClass A

Critical Aseptic Processing Areas.Critical Aseptic Processing Areas.

Sterile Product and Product Contact Material are exposed to the Sterile Product and Product Contact Material are exposed to the
environment.environment.

High Risk Operations : Filling.High Risk Operations : Filling.

Considered Considered Class 100 environments Class 100 environments in operation and at rest.in operation and at rest.

Flow of air is Flow of air is unidirectional.unidirectional.

19. Class BClass B

Aseptic Processing Areas where Sterile Product and Product Contact Aseptic Processing Areas where Sterile Product and Product Contact
Material are protected from the environment. Material are protected from the environment.

Utilized for sterile product transport.Utilized for sterile product transport.

The background environment for grade A areas.The background environment for grade A areas.

Considered Considered Class 10,000 environments Class 10,000 environments “in operation” and “in operation” and Class 100 Class 100
environments environments under “ at rest” conditions.under “ at rest” conditions.

Flow of air isFlow of air is non unidirectional non unidirectional..

20. Class CClass C

Non- Critical Areas where product or material are exposed to the Non- Critical Areas where product or material are exposed to the
environment , product sterilization has not yet performed : Formulationenvironment , product sterilization has not yet performed : Formulation

Support Areas for non sterile production activities and preparation of Support Areas for non sterile production activities and preparation of
components ,equipment ,etc for sterilizationcomponents ,equipment ,etc for sterilization

Considered Considered Class 100,000 Class 100,000 environment in the dynamic state and environment in the dynamic state and
Class 10,000Class 10,000 environment under static conditions environment under static conditions

21. Class EClass E

Non – critical support areas for production activities.Non – critical support areas for production activities.

Controlled product transport hallways used to move sterilized product Controlled product transport hallways used to move sterilized product
for labeling ,packaging and storage.for labeling ,packaging and storage.

22. GowningGowning
Primary gowningPrimary gowning Secondary gowningSecondary gowning
Access to Class EAccess to Class E
(General area)(General area)
-Offices-Offices
-Control Room-Control Room
-Packaging area-Packaging area
-Ware house-Ware house
-Workshop-Workshop
Access to Class CAccess to Class CAccess to Class BAccess to Class B
--Vial WashingVial Washing
-Media preparation-Media preparation
-Washing & Preparation area-Washing & Preparation area
--Mixing areaMixing area
-Filling area& tank storage -Filling area& tank storage
areaarea
- - Sterile lab.Sterile lab.

23. Gowning Procedure For Entry

24. Gowning guidelinesGowning guidelines
Street ClothesStreet ClothesClass EClass EClass CClass CClass A&BClass A&B
CleanlinessCleanlinessNot cleanNot clean

(

(
dusty dusty
clothesclothes)

)

CleanCleanCleanCleanCleanClean
Particles Particles
generationgeneration
Fibers are loosely Fibers are loosely
connected :generates connected :generates
particlesparticles
Filaments are continuous Filaments are continuous
(monofilament ) : (monofilament ) :
generates no particlesgenerates no particles
Particles Particles
BarrierBarrier
Fabric has holes through Fabric has holes through
which air passes: not a which air passes: not a
barrierbarrier
Weave is tight : consider Weave is tight : consider
as barrieras barrier
SterilitySterilityNot sterileNot sterileNot sterileNot sterileNot sterileNot sterilesterilesterile

25. QuestionsQuestions??????