Project co-financed by

European Union Project co- financed

by Asean

ASEAN GMP TRAINING MODULE

PERSONNEL
Prepared by
Rosni Jair - Brunei Darussalam

Approved by
ASEAN GMP Team

Endorsed by
ASEAN Cosmetic Committee
European Committee
for Standardization
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Project co-financed by
European Union Project co- financed
by Asean

ASEAN GMP TRAINING MODULE

PERSONNEL
Prepared by

Technical Working Group 2

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Project co-financed by
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CONTENT OF PRESENTATION
 Objectives
 Scope
 Principle
 General
 Key personnel
 Training
 Personal hygiene
 Related hyperlink documents
 References

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INTRODUCTION

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INTRODUCTION
 Companies can make investments and buy facilities
and equipment. However, the greatest resource that
a company has is its personnel.

 Cosmetic company should ensure that there are

sufficient qualified key personnel and staff s who are
adequately trained in the principles and application of
GMP to ensure:
• protection of the health of all personnel;
• protection of the product from contamination; and
• protection of product quality

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OBJECTIVE

 To provide in-depth understanding

regarding general requirement of the
personnel in the cosmetic
manufacturing facilities
 To be able to disseminate the
information on the organisation
structure

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SCOPE

The module will apply to all

personnel in the cosmetic
manufacturing facilities, such as :
 manufacturing
 quality control
 warehouse etc.

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GENERAL
REQUIREMENTS

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PRINCIPLE
 Establishment and maintenance of satisfactory system
of QA and manufacturing of cosmetic products rely on
people.
 Sufficient qualified personnel to carry out tasks
 Individual responsibilities must be clearly understood
by individuals concerned and recorded
 All personnel should be aware of the principles
of cosmetic GMP that affect them and should receive
initial and continuing training including hygiene
instructions, relevant to their job descriptions

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GENERAL REQUIREMENT
 Adequate number of qualified people
with practical experience versus
procedures, processes, equipment s

 An individual’s responsibilities should

not be so extensive as to present a risk
to quality

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GENERAL REQUIREMENT (cont.)

 Individual written job description
 Adequate authority to carry out responsibilities
 No gaps or unexplained overlaps
 May delegate to designated qualified staff
 Organization chart shall indicate the full name of responsible
staff

Managing Director

Head of Head of Head of

Sales & Marketing Production Quality Control

Sales Marketing Processing Packaging IPQC

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GENERAL REQUIREMENT (cont.)

Prevent unauthorized access to

production areas, storage areas,
quality control
Stop personnel who do not work in
these areas using them as
passageways

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KEY PERSONNEL
 Key personnel positions include:
• Head of Production
• Head of Quality Control
 Heads of Production and Quality Control should be
independent of each other
 For a large organisation, it may be necessary to
delegate some of the functions; however, the
responsibility cannot be delegated

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KEY PERSONNEL QUALIFICATION

 Key personnel should be appropriately qualified and/or possess
adequate practical experience
 Examples of desirable qualifications include:
• chemistry, biochemistry, chemical engineering, microbiology,
pharmaceutical sciences and technology, pharmacology and
toxicology, physiology, cosmetic science; or
• GMP-related subjects/trainings relevant to the responsibilities
to be undertaken
 Practical experience.
• Manufacture and quality assurance
• Under professional guidance
 Able to take difficult decisions in a professional and scientific way,
• resolve the problems encountered in manufacturing and QC.

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HEAD OF PRODUCTION
The head of production shall be adequately trained and experienced
in cosmetic manufacturing and shall cover the following:
 Manufacture and storage according to appropriate
documentation
 Approval and implementation of production instructions, in-
process QC and ensure strict implementation
 Evaluation of production records and signed by designated
person before passing to QC
 Maintenance of production department, premises and
equipment
 Calibration of manufacturing equipment performed, recorded
and reports made available
 Initial and continuing training of production personnel

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HEAD OF QUALITY CONTROL

The head of quality control shall be adequately trained and experienced in
the field of quality control and shall cover the following:
 Approval and rejection of materials, packing materials, intermediates,
bulk and finished products
 Evaluation of batch records
 Carrying out of necessary testing
 Approval of quality control procedures such as sampling instructions,
specifications, test methods, and other QC procedures
 Approval and monitoring of all contract analysis
 Maintenance of quality laboratory, including equipment and laboratory
apparatus
 Calibration of quality control equipment
 Initial and continuous training of QC personnel

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SHARED RESPONSIBILITIES
Heads of Production and Quality Control may share some responsibilities relating to
quality, such as:

 authorization of written procedures (SOPs) and other documents, including

amendments
 environmental monitoring and control, and plant hygiene
 training, including application and principles of GMP
 approval and monitoring of suppliers
 monitoring of storage conditions for materials and products
 Performing and evaluating in-process controls
 retention of records
 monitoring compliance with GMP
 Ensuring corrective and preventive actions are implemented

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EXAMPLE: CLEAR RESPONSIBILITY

ABC Cosmetic Factory Ltd.
SOP No. :
Standard Section : 01 Organization and Personnel 1.2
Revision No. :
Operating Title : Plant Manager 00
Effective Date:
Procedure 02.01.98
Date Issued Supersedes :
30.12.97 N/A

Prepared by : Approved by : Page 1 of 4

Full Name and Full Name and Signature
Signature

1.0 Purpose
To outline the basic responsibilities of plant manager.

2.0 Scope
This SOP applies to plant manager in the plant addressed below.

3.0 Responsibility
It is the responsibility of the Plant Manager to define the responsibilities of the key personnel, to ensure that this SOP is updated accordingly
with changes in their responsibilities, and to clearly relay these responsibilities and job duties to these personnel. It is the responsibility of the
key personnel addressed in this SOP to adhere to and perform their functions and report to the Plant Manager as necessary.

4.0 Basic Responsibilities

4.1 To ensure that adequate resources are being effectively distributed in each single operation.
4.2 Supervise and provide technical supports to quality control, production and administration functions.
4.3 Responsible to review and approve all production and process related documents and SOPs.
4.4 Ultimate responsible of the quality system of the plant.
4.5 To ensure that good manufacturing and safety practices are being exercised and implemented in the plant.
4.6 Responsible to maintain all staff qualification records and identify the training needs for key personnel.
4.7 Responsible to review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness.
4.8 Prompt the QC functions, for initiating any investigation and measures.

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EXAMPLE: JOB DESCRIPTION

Plant Manager
 To ensure that adequate resources are being effectively
distributed in each operation.
 Supervise and provide technical support s to quality control,
production and administration functions.
 Responsible to review and approve all production and process
related documents and SOPs.
 Responsible for the quality system of the plant.
 To ensure that good manufacturing and safety practices are
being exercised and implemented in the plant.
 Responsible to maintain all staff qualification records and
identify the training needs for key personnel.
 Responsible to review the quality system at defined intervals
sufficient to ensure its continuing suitability and effectiveness.
 Prompt the QC functions, for initiating any investigation and
measures.
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PERSONNEL TRAINING
 Training, in accordance with a written programme for
• all personnel assigned in production; or
• in quality control laboratories; and
• those whose functions may affect the quality of the product

 Training upon hiring and on continuing basis on theory and

practice of GMP and their duties
 Training shall be approved by either the head of Production or QC
as appropriate
 Training records should be kept
 Training before undertaking any new task

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PERSONNEL TRAINING (cont.)

 Specific training must be given for staff in special areas,
e.g.
• handling hazardous materials
• working in an area where there is potential health
hazard
 The concept of QA and its understanding and
implementation should be fully discussed during training
 Practical effectiveness should be periodically assessed e.g.
assessment tests, number of rejects, product complaint,
return products

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VISITOR OR UNTRAINED PERSONNEL

 Must be given information in advance,

particularly about
• personal hygiene; and
• protective clothing requirements
 Must be accompanied and closely
supervised at all times

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PERSONNEL HYGIENE
 All personnel must undergo health
examination
 Trained in the practice of personnel
hygiene
 Illness or open lesions – not allowed
 Report to supervisors any conditions
adversely affecting product quality

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PERSONNEL HYGIENE (cont.)

 Avoid direct contact of operator’s hands on
products including starting materials
 Wear clean body covering
 Smoking, eating, drinking, chewing and keeping
materials not related to production not permitted
 Use of protective clothing in production areas

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RELATED HYPERLINK DOCUMENTS

 Trainer manual of personnel module

 ASEAN GMP Personnel Hygiene

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REFERENCES

1. ASEAN Guidelines for Cosmetic GMP (2003)

2. WHO - EDM, Basic Principle of GMP: Personnel
(2004)

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