The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked. The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively.

1. Module 8 | Slide 1 of 29 January 2006
GMP TRAINING
ON
PERSONNEL
Presented by:
MD. ZAKARIA FARUKI
Manager & Head of Quality Assurance
Silva Pharmaceuticals Limited
Date of Training: August 20, 2022
GMP
Slide 1 of 31

2. Module 8 | Slide 2 of 29 January 2006
Personnel
Basic Principles of GMP
9
Companies can make investments and buy facilities and
equipment. However, the greatest resource that a
company has is its personnel. But human resources
also need a lot of attention. If a company does not have
correctly educated, trained and motivated people
working in its factory or laboratory, it is necessary to
provide training in order to overcome any inherent
weaknesses and to build upon existing strengths.
GMP
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3. Module 8 | Slide 3 of 29 January 2006
Personnel
Objectives
 To review general issues related to personnel
 To review requirements for key personnel
 To review the training of personnel
 To consider some specific issues
GMP
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4. Module 8 | Slide 4 of 29 January 2006
9.1
Personnel
Principle
 Establishment and maintenance of satisfactory system of QA,
manufacture and control of products and actives rely on people.
 Must be sufficient qualified personnel to carry out tasks
 Individual responsibilities must be clearly defined and understood
by individuals concerned
 Written job descriptions
 All personnel should be aware of the principles of GMP that affect
them
GMP
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Slide 4 of 31

5. Module 8 | Slide 5 of 29 January 2006
9.2
Personnel
General (1)
Personnel requirements:
 Adequate number of persons
 With necessary qualifications
 With practical experience
 An individual’s responsibilities should not be so extensive as to
present a risk to quality
GMP
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6. Module 8 | Slide 6 of 29 January 2006
9.3
Personnel
General (2)
 All responsible staff should have specific duties recorded in
individual written job descriptions
 Have adequate authority to carry out responsibilities
 May delegate to designated deputies with qualifications
 No gaps or unexplained overlaps
 Organization chart
GMP
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Slide 6 of 31

7. Module 8 | Slide 7 of 29 January 2006
Basic Principles of GMP
Organization Chart
 This is NOT what
it should look like
GMP
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Slide 7 of 31

8. Module 8 | Slide 8 of 29 January 2006
9.4
Personnel
General (3)
 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
GMP
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Slide 8 of 31

9. Module 8 | Slide 9 of 29 January 2006
9.5
Personnel
General (4)
 Prevent unauthorized access
 To production areas
 Storage areas
 Quality control
 Stop personnel who do not work in these areas using them as
passageways
GMP
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Slide 9 of 31

10. Module 8 | Slide 10 of 29 January 2006
Basic Principles of GMP
GMP
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Slide 10 of 31

11. Module 8 | Slide 11 of 29 January 2006
9.6
Personnel
Key Personnel (1)
Key personnel (which normally should be
full-time) positions include:
 Authorized person
 Head of Production
 Head of Quality Control
 May delegate functions – not responsibility
 Heads of Production and Quality Control should be
independent of each other
 Head of Quality - maintains all compliance issues of the
Organization.
GMP
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Slide 11 of 31

12. Module 8 | Slide 12 of 29 January 2006
9.7
Personnel
Key Personnel (2)
Should posses appropriate qualifications
 Scientific education such as:
 chemistry or biochemistry
 chemical engineering
 microbiology
 pharmaceutical sciences and technology
 pharmacology and toxicology
 physiology; or
 other related science subjects relevant to the responsibilities
to be undertaken
GMP
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Slide 12 of 31

13. Module 8 | Slide 13 of 29 January 2006
9.7
Personnel
Key Personnel (3)
Should posses appropriate experience
 Practical experience
 Manufacture and quality assurance
 Preparatory period under professional guidance sometimes
needed
 Education and experience should enable personnel to take
difficult decisions in an independent, professional and scientific
way
 resolve the problems encountered in manufacturing and QC
GMP
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14. Module 8 | Slide 14 of 29 January 2006
Personnel
Shared Responsibilities (1)
Heads of Production and Quality Control may share/jointly exercise some
responsibilities relating to quality:
 authorization of written procedures (SOPs) and other documents,
including amendments
 monitoring and control of manufacturing environment & plant hygiene
 process validation and calibration
 training, including application and principles of QA
 approval and monitoring of suppliers and contract acceptors
9.8
GMP
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15. Module 8 | Slide 15 of 29 January 2006
Personnel
Shared Responsibilities (2)
 Designation and monitoring of storage conditions for materials
and products
 Performing and evaluating in-process controls
 Retention of records
 Monitoring compliance with GMP
 Inspection, investigation, and taking of samples to monitor
factors which may affect quality 9.8
GMP
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16. Module 8 | Slide 16 of 29 January 2006
Personnel
Head of Production: Responsibilities (1)
 Product production and storage according to appropriate
documentation
 Approval and implementation of production instructions,
in-process QC and ensure strict implementation
 Ensures that production records are evaluated and signed by
designated person
9.9
GMP
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Slide 16 of 31

17. Module 8 | Slide 17 of 29 January 2006
Personnel
Head of Production: Responsibilities (2)
 Checks maintenance of production department, premises and
equipment
 Ensures process validation and calibration performed,
recorded, and reports are made available
 Ensures initial and continuous training of production personnel
9.9
GMP
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Slide 17 of 31

18. Module 8 | Slide 18 of 29 January 2006
Personnel
Head of Quality Control: Responsibilities (1)
 Approval or rejection of materials, e.g. packing materials,
intermediates, bulk and finished products, in accordance with
specifications
 Evaluation of batch records
 Ensures carrying out of necessary testing
 Ensures of quality control procedures, e.g. sampling and testing;
specifications
9.10
GMP
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Slide 18 of 31

19. Module 8 | Slide 19 of 29 January 2006
Personnel
Head of Quality Control: Responsibilities (2)
 Approval and monitoring of all contract analysis
 Checks maintenance of quality department, premises and
equipment
 Ensures validation (including analytical procedure validation)
and calibration of control equipment
 Ensures initial and continuous training of QC personnel
9.10
GMP
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Slide 19 of 31

20. Module 8 | Slide 20 of 29 January 2006
Personnel
Authorized person: Responsibilities (1)
 Compliance with technical and regulatory requirements
 Approval of all procedures like SOP, SOP & GMP Documents
 Approval of the release of finished product for sale
 Establishment and implementation of quality system
 Supervision of self-inspections and quality audits
 Development of quality manual
9.11
GMP
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21. Module 8 | Slide 21 of 29 January 2006
Personnel
Authorized person: Responsibilities (2)
 Oversight of the QC department
 Participation in external audits and vendor audits
 Participation in validation programmes
 May delegate approval of release of product
through approved procedure
 Normally by QA by means of batch review
9.12, 9.13
GMP
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Slide 21 of 31

22. Module 8 | Slide 22 of 29 January 2006
Personnel
Person releasing the batch should ensure: (1)
 Each batch meets manufacturing and marketing authorization
requirements
 Principles and requirements of GMP are met
 All checks and tests have been performed
 Production conditions and manufacturing records
 Planned changes and deviations reported - including where
necessary to drug regulatory authority
9.14 a - e
GMP
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Slide 22 of 31

23. Module 8 | Slide 23 of 29 January 2006
Personnel
Person releasing the batch should ensure: (2)
 Additional sampling, inspection, checks and tests had been
done when required
 All production and control documents are completed and
endorsed
 Audits, inspections and spot-checks were done
 QC approval has been given
 All other relevant factors have been considered
9.14 f - j
GMP
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Slide 23 of 31

24. Module 8 | Slide 24 of 29 January 2006
Personnel
Training (1)
 Training, in accordance with a written, approved programme
 all personnel whose duties take them into production areas; or
 into control laboratories; and
 for others whose activities could affect the quality of the
product including technical, maintenance and cleaning
personnel
 Induction and continuing training
 on theory and practice of GMP and their duties
 training records should be kept
 practical effectiveness checked
 training before undertaking any new task
10.1, 10.2
GMP
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25. Module 8 | Slide 25 of 29 January 2006
Personnel
Training (2)
 Specific training for staff in special areas, e.g.
 Where contamination is a hazard
 Including clean areas; or
 Areas where highly active, toxic, infectious, sensitizing
materials are handled
 The concept of QA should be fully discussed during training to
facilitate proper understanding to ensure its implementation
10.3, 10.4
GMP
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26. Module 8 | Slide 26 of 29 January 2006
10.5
Personnel
GMP
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Visitors or Untrained Personnel
Preferable not to enter production and control areas. If this is
unavoidable then:
 They must be given information in advance, particularly about
 personal hygiene
 protective clothing requirements
 Must be accompanied and closely supervised at all times

27. Module 8 | Slide 27 of 29 January 2006
10.6
Personnel
Consultants and contract staff
 Should be qualified for the services provided
 Training records maintained
 Records should prove qualifications
GMP
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28. Module 8 | Slide 28 of 29 January 2006
Personnel
Group Session
 What do you think will be the key personnel issues to arise
during an inspection?
 What sort of responses do you think you should give to these
issues when they become apparent?
GMP
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Slide 28 of 31

29. Module 8 | Slide 29 of 29 January 2006
Personnel
Possible Issues – I
 Limited number of staff
 Inadequate qualifications
 Inadequate experience
 Owner interferes in quality decisions
 Lack of means to develop training materials
GMP
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Slide 29 of 31

30. Module 8 | Slide 30 of 29 January 2006
Personnel
Possible Issues – II
 Company procedures take precedence over local legislation
 Unclear organization diagram
 Staff movement
 Inadequate training records
 Illness
GMP
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Slide 30 of 31

31. Module 8 | Slide 31 of 29 January 2006
Personnel
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GMP
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