Basic Principles of GMP
Personnel
Workshop on
GMP and Quality Assurance of TB products
Kuala Lumpur
Malaysia, 21 – 25 February 2005
Maija Hietava
M.Sci.Pharm
Part One, 9 - 11
Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals
Cluster
Tel: +41.22.791.3598 Fax: +41.22.791.4730
World Health Organization
E-mail: hietavam@who.int
WHO - PSM
Personnel
Objectives
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To review general issues related to personnel
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To review requirements for key personnel
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To review the training of personnel
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To consider some specific issues
WHO - PSM
Personnel
Principle

Establishment and maintenance of satisfactory system of
QA and manufacturing of products and actives rely on
people.

Must be sufficient qualified personnel to carry out tasks

Individual responsibilities must be clearly understood by
individuals concerned

All personnel should be aware of the principles
of GMP that affect them
Part One 9.1
WHO - PSM
Personnel
General - I

Adequate number of qualified people with practical
experience

An individual’s responsibilities should not be so
extensive as to present a risk to quality
Part One 9.2
WHO - PSM
Personnel
General - II

Individual written job description
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Organization Chart
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No gaps or unexplained overlaps
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Adequate authority to carry out responsibilities
Part One 9.3
WHO - PSM
Personnel
Question no 1

What is the main resource of the
pharmaceutical industry ???
Part One 9.3
WHO - PSM
Personnel
General - III

Individuals must receive training in GMP:
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
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initial training
dedicated training for the job in question
continuing training
including hygiene standards
Motivated to
 support the establishment of high quality standards
 maintain high-quality standards
Part One 9.4
WHO - PSM
Personnel
General - IV

Prevent unauthorized access to production, storage,
quality control

Stop personnel who do not work in these areas using
them as passageways
Part One 9.5
WHO - PSM
Personnel
Key Personnel - I
Key personnel (which normally should be
full-time) positions include:

Head of Production

Head of Quality Control

Head of Sales and Distribution

Heads of Production and Quality Control should
be independent of each other
Part One 9.6 – 9.7
WHO - PSM
Personnel
Key Personnel - II
Key personnel should posses the qualifications of:

Scientific education. For example:
 chemistry, biochemistry, chemical engineering, microbiology,
pharmaceutical sciences and technology, pharmacology and
toxicology, physiology; or
 other related science subjects relevant to the responsibilities to be
undertaken

Practical experience.
Part One 9.7
 under professional guidance
 able to take difficult decisions in a professional and scientific way,
 resolve the problems encountered in manufacturing and QC.
WHO - PSM
Personnel
Shared Responsibilities – I
Heads of Production and Quality Control may share some
responsibilities depending on national regulations:

authorization of written procedures (SOPs) and other
documents, including amendments

environmental monitoring and control, and plant hygiene

process validation and calibration

training, including application and principles of QA

approval and monitoring suppliers
Part One 9.8
WHO - PSM
Personnel
Shared Responsibilities – II

designation and monitoring of storage conditions
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retention of records

monitoring compliance with GMP

inspection, investigation, and taking of samples to
monitor factors which may affect quality
Part One 9.8
WHO - PSM
Personnel
Head of Production Responsibilities - I

Product production and storage according to
appropriate documentation

Approval and implementation of production
instructions, in-process QC and ensure strict
implementation

Evaluate production records; signed by designated
person before passing to QC
Part One 9.9
WHO - PSM
Personnel
Head of Production Responsibilities - II
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
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Maintenance of production department, premises
and equipment
Process validation and calibration performed,
recorded and reports made available
Training of production personnel; initial and
continuing
Part One 9.9
WHO - PSM
Personnel
Head of Quality Control Responsibilities - I
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
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Approval or rejection of materials, packing materials,
intermediates, bulk and finished products
Evaluation of batch records
Carrying out of necessary testing
Approval of quality control procedures: sampling
instructions, specifications, test methods, and other
QC procedures
Part One 9.10
WHO - PSM
Personnel
Head of Quality Control Responsibilities - II
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Approval and monitoring of all contract analysis
Maintenance of quality department, premises and
equipment
Validation, including analytical procedure validation,
and calibration of control equipment
Initial and continuous training of QC personnel
Part One 9.10
WHO - PSM
Personnel
Useful reference documents for inspectors:

Organization Chart
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Job descriptions
WHO - PSM
Personnel
Training - I

Training, in accordance with a written programme for
 all personnel whose duties take them into production; or
 into control laboratories; and
 for others whose activities could affect the quality of the product

On induction and continuing
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

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on theory and practice of GMP;
approved by either the head of Production or QC as appropriate
training records should be kept
Part One 10.11 - 10.12
training before undertaking any new task
WHO - PSM
Personnel
Training - II

Staff in special areas
 clean areas; or
 working with highly active, toxic, infectious, sensitizing materials
should be given specific training

The concept of QA and its understanding and
implementation should be fully discussed during training
Part One 10.3 - 10.4
WHO - PSM
Personnel
Training - III

What can be a training session to be documented
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Seminar or congress – in or outside the company
Training in the comapany
Regular department meeting dealing with quality matters
Training of SOPs
Etc.
Etc.
WHO - PSM
Personnel
Training – IV- Assessment of training

Training is successful when
 employee sees his/her work as part of the totality of quality work,
which has a direct input in the safety and quality of medicines
 employee understands that she/he can cause a lot of trouble and
damage for the users of medicines and also problems to her/his
employer , if if she/he is careless and don't follow the guidelines
and SOPs
 as a result of the training there is a knowledgeable, motivated and
satisfied employee
WHO - PSM
Personnel
Visitors or Untrained Personnel
Preferable not to take them in. If this is unavoidable, for
example GMP inspectors:

Must be given information in advance; particularly about
 personal hygiene; and
 protective clothing requirements

Must be accompanied and closely supervised at all times
Part One 10.5
WHO - PSM
Personnel
Question no 2

What has to be planned and continuous in
pharmaceutical industry, which normally
also motivates personnel???
Part One 10.5
WHO - PSM
Personnel
Possible Problems

Limited number of staff

Inadequate qualifications

Inadequate experience

Owner interferes in quality decisions

Lack of means to develop training materials
WHO - PSM
Personnel
Possible Problems

Company procedures take precedence over local
legislation

Unclear organisation chart

Staff movement

Inadequate training records

Illness
WHO - PSM