Basic Principles of GMP

Personnel

Part One, 10

Module 8

Slide 1 of 22

WHO - EDM

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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WHO - EDM

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 10.1

Module 8

Slide 3 of 22

WHO - EDM

Personnel
General - I

Adequate number of qualified people with

practical experience

An individuals responsibilities should not be so

extensive as to present a risk to quality

Part One 10.2

Module 8

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WHO - EDM

Personnel
General - II

Individual written job description

Organization Chart

No gaps or unexplained overlaps

Adequate authority to carry out

responsibilities

Part One 10.3

Module 8

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WHO - EDM

Personnel
General - III

Individuals must receive training in GMP:

initial training
continuing training
including hygiene standards

Motivated to
support the establishment
maintain high-quality standards
Part One 10.4

Module 8

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WHO - EDM

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 10.5

Module 8

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WHO - EDM

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 10.6 10.7

Module 8

Slide 8 of 22

WHO - EDM

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.
under professional guidance
Part One 10.7
able to take difficult decisions in a professional and scientific
way,
resolve the problems encountered in manufacturing and QC.

Module 8

Slide 9 of 22

WHO - EDM

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 Part

QA One 10.8

approval and monitoring suppliers

Module 8

Slide 10 of 22

WHO - EDM

Personnel
Shared Responsibilities II

designation and monitoring of storage

conditions

retention of records

monitoring compliance with GMP

inspection, investigation, and taking of

samples to monitor factors which may affect
Part One 10.8
quality

Module 8

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WHO - EDM

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 10.9

Module 8

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WHO - EDM

Personnel
Head of Production Responsibilities - II

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 10.9

Module 8

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WHO - EDM

Personnel
Head of Quality Control Responsibilities - I

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 10.10

Module 8

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WHO - EDM

Personnel
Head of Quality Control Responsibilities II

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 10.10

Module 8

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WHO - EDM

Personnel
Useful reference documents for
inspectors:

Organization Chart

Job descriptions

Module 8

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WHO - EDM

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

on theory and practice of GMP;
approved by either the head of Production or QC as
appropriate
Part One 10.11 - 10.15
training records should be kept
training before undertaking any new task

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WHO - EDM

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 10.11 - 10.14

Module 8

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WHO - EDM

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 10.15

Module 8

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WHO - EDM

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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WHO - EDM

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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WHO - EDM

Personnel
Possible Issues II

Company procedures take precedence over

local legislation

Unclear organisation diagram

Staff movement

Inadequate training records

Illness

Module 8

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WHO - EDM