Personnel - CGMP Training

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The key takeaways are that companies' greatest resource is their personnel, and cosmetic companies must ensure personnel are qualified, trained, and protect health, products, and quality.

General requirements for personnel include having an adequate and qualified number of people, clear individual responsibilities, organization charts, and job descriptions.

The principles of personnel training are training all relevant personnel on induction and continuing training, keeping training records, and periodically assessing training effectiveness.

Project co-financed by

European Union Project co- financed


by Asean

PERSONNEL

European Committee 1
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

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 staffs 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

European Committee 2
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

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

European Committee 3
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

SCOPE

The module will apply to all


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

European Committee 4
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

GENERAL
REQUIREMENTS

European Committee 5
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

PRINCIPLE
 Establishment and maintenance of satisfactory
system of QA and manufacturing of cosmetic
products relies on people.
 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 cosmetic GMP that affect them and
continuing training including hygiene
instructions, relevant to their needs
European Committee 6
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

GENERAL REQUIREMENT (1)


• Adequate number of qualified people
with practical experience versus
procedures, processes, equipments

• An individual’s responsibilities should


not be so extensive as to present a risk
to quality

European Committee 7
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

GENERAL REQUIREMENT (2)


• Individual written job description
• Adequate authority to carry out
responsibilities
• No gaps or unexplained overlaps
• Organization chart
Managing Director

Head of Head of Head of


Engineering/Maintenance Production Quality Control

Maintenance New Equipment Processing Packaging IPQC

European Committee 8
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

GENERAL REQUIREMENT (3)

• Prevent unauthorized access to


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

European Committee 9
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

KEY PERSONNEL
 Key personnel (normally full time) 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 – may be necessary to
delegate some of the functions; however, the
responsibility cannot be delegated

European Committee 10
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

PERSONNEL TRAINING (1)


 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
 training records should be kept
 training before undertaking any new task

European Committee 11
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

PERSONNEL TRAINING (2)

 Staff in special areas, e.g.


 working with hazardous materials should be
given specific training
 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

European Committee 12
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

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

European Committee 13
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

PERSONNEL HYGIENE (1)


 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 affect the product quality

European Committee 14
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

PERSONNEL HYGIENE (2)


 Avoid direct contact of operator’s hands
and products including starting/ packaging
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
European Committee 15
for Standardization
Implementing Agency
Project co-financed by
European Union Project co- financed
by Asean

European Committee 16
for Standardization
Implementing Agency

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