Transcript Basic Principles of GMP Personnel Module 8 | Slide 1 of 29 January 2006 Personnel Objectives  To review general issues related to personnel  To review requirements.

Basic Principles of GMP
Personnel
9
Module 8
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Slide 1 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
Module 8
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Slide 2 of 29
January 2006
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
9.1
Module 8
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Slide 3 of 29
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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
9.2
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Slide 4 of 29
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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
9.3
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Basic Principles of GMP
Organization chart
 This is NOT what it should
look like
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Slide 6 of 29
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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
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9.4
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
9.5
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Basic Principles of GMP
Module 8
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Slide 9 of 29
January 2006
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
9.6
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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
9.7
 physiology; or
 other related science subjects relevant to the responsibilities
to be undertaken
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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
9.7
 resolve the problems encountered in manufacturing and QC
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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
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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
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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
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Slide 15 of 29
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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
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Slide 16 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
 Approval of quality control procedures, e.g. sampling and testing;
specifications
9.10
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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
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Personnel
Authorized person: Responsibilities (1)
 Compliance with technical and regulatory requirements
 Approval of the release of finished product for sale
 Establishment and implementation of quality system
 Development of quality manual
 Supervision of self-inspections and quality audits
9.11
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Slide 19 of 29
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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
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Slide 20 of 29
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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
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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
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Slide 22 of 29
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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
10.1, 10.2
 practical effectiveness checked
 training before undertaking any new task
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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
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Personnel
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
10.5
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Personnel
Consultants and contract staff
 Should be qualified for the services provided
 Training records maintained
 Records should prove qualifications
10.6
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Slide 26 of 29
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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?
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Slide 27 of 29
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Personnel
Possible Issues – I
 Limited number of staff
 Inadequate qualifications
 Inadequate experience
 Owner interferes in quality decisions
 Lack of means to develop training materials
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Personnel
Possible Issues – II
 Company procedures take precedence over local legislation
 Unclear organization diagram
 Staff movement
 Inadequate training records
 Illness
Module 8
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Slide 29 of 29
January 2006