GMP -Personnel

requirements
SESSION 03
Paul,SAMBA
 Learning Tasks

By the end of this session students are expected

to be able to:
• List general possible issues related to
personnel in GMP
• List general principles related to personnel in
GMP
• Explain requirements for key personnel in GMP
• Review the training of personnel in GMP
 General Possible Issues Related to
Personnel in
The issues will be around a “lack of skills” and
“resources” to comply with all the requirements of
GMP
• Limited staff numbers may mean that people are
under pressure to perform. They may be trying to do
too much. There may be a lack of deputies during
times of illness or holidays.
• Recruited staff may have inadequate qualifications.
• Recruited staff may have inadequate experience or
experience in an inappropriate area. Sometimes the
owner recruits relatives who are inadequately
qualified or experienced.
• The owner may interfere with quality
decisions, particularly if orders are required
urgently or are very valuable. Senior staff may
have difficulty in combating this, since it may
cost them their jobs.
• Smaller companies may have no means to
develop training materials to educate their
staff in the requirements of GMP. They do not
become members of the local manufacturers’
association because of cost. They do not then
have access to training programmes that are
available through the association.
• Subsidiaries of multinational companies may claim
that company procedures or standards take
precedence over local legislation. If this is claimed, it
will be most unusual since all multinationals require
local companies to conform first to local legislation.
It will be worth exploring with the company what
benefits are obtained by not conforming to local
legislation.
• Large organizations often move people around
through promotion, training, recruitment or
relocation. In so doing they can lose sight of the
requirements of GMP. Managers can be promoted
into positions for which they are not qualified or
experienced.
• Companies may not keep adequate training
records even though people are apparently
undergoing training.
• As with small companies, large companies
may have personnel policies that penalize
people. The problem is that if people are not
going to be paid when sick or injured, they
may work on under circumstances that create
a risk to the product.
 General Principles Related to Personnel in GMP
• For successful and good quality pharmaceutical production, it
is essential to have people with sufficient knowledge and
experience to undertake the work. They must have the
authority and the means to do that work, and there must be
enough of them available to carry out tasks effectively.
• It is most important that the people that are recruited are
selected from a group that can meet the requirements.
• It is not recommended to recruit people to work in
manufacturing areas if they are unable to read the
instructions for their safety and for product quality.
• A medical examination should be included during the
recruitment processes. Operators working with cytotoxic
products may need blood tests at the time of recruitment and
at six monthly intervals thereafter.
• Operators who will work on visual inspection
processes should also undertake an eye test at the
time of recruitment with a regular check on a
periodic basis afterwards.
• A major and most common problem is that of
insufficient people available to do the work. It is of
little value having just one person well qualified and
experienced, with no backup staff. What then
happens in the case of sickness or holiday? This can
be a very difficult area, and one which is harder for
smaller companies than a multinational company or
similar.
• The employment of a well-qualified, but
inexperienced person to manage, for example,
quality. An illustration of this is the
recruitment by the owner of a small company
of a relative -- who is newly qualified, but
completely inexperienced to run a laboratory
or manufacturing area
• The duties incumbent upon any one individual should
not be so extensive that he/she cannot cope, resulting
in a risk to quality of the product.
• Staff must have a clear job description which tells
them and the rest of the company what their role is,
what their responsibilities are and what authority they
have to carry out their tasks. The company should also
have a written organization chart. The combination of
organization chart and written job descriptions
enables the company to see quickly whether there
are any gaps or whether there are any areas of
overlap, owing to too many people being involved.
The organization chart should make clear and ensure
the independence of QA/QC from production.
• Personnel involved in QA/QC must have the authority
to carry out their responsibilities. This is very easy to
say and sometimes not so easy to ensure. Problems
can emerge in every size of company, from small
private companies to very large multinational
enterprises. They arise because of a combination of
human interactions, and the pressures placed on
people by the business considerations
• All personnel involved with materials and products
should receive GMP training. This training should
commence upon recruitment and continue
throughout employment. The training should be
appropriate to their needs and position within the
company, and should include training in hygiene
standards.
• Personnel policies should be designed to encourage
people to support the development and
maintenance of high quality standards in all work
performed.
• The company should prevent people who have not
been properly trained from entering any production,
storage or quality control area without strict
supervision. For example: it should not be the case
that people from accounts are allowed to walk
through the factory to get to the warehouse to pick
up or deliver invoices. Access to all other areas of
the company should be organized so that no entry to
production, storage or laboratory areas is necessary.
 Requirements for Key Personnel in
GMP 1/7
Key personnel include the following
1. The heads of production,
2. Quality control personnel
3. Sales and distribution personnel
4. Authorized person who releases
product for sale
 Requirements for Key Personnel in
GMP 2/7
• Normally they should all be full-time
positions.
• The heads of production and quality control
should not report to one another (although
they may both report to a technical director)
but may share certain responsibilities.
• In large organizations, it may be necessary to
delegate some of the functions; however, the
responsibility cannot be delegated.
 Requirements for Key Personnel in GMP 3/7

• The principle is that there must be independence of quality

control from production.
• These key personnel must have the education and experience
which is appropriate to their positions.
• Heads of Production and Quality Control should be independent
of each other
• Should possess appropriate qualifications Scientific education
such as:
1. chemistry or biochemistry
2. chemical engineering
3. microbiology
4. pharmaceutical sciences and technology
5. pharmacology and toxicology
6. physiology; or
7. other related science subjects relevant to the responsibilities to be
 Requirements for Key Personnel in
GMP 4/7
• The WHO GMP text part one, section 9.7 refers to some
of the acceptable qualifications of key personnel and it
goes into a lot of detail.
• Key personnel should first of all have the educational
background specified by local legislation and with the
requirements set out in company policy. This will include
a combination of 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.
Requirements for Key Personnel in GMP 5/7

• In particular, the GMP text talks about gaining

experience not in a haphazard way, but under specific
guidance of an expert. This is in order to equip
personnel with an ability to take difficult decisions in
a professional and scientific way, and to resolve the
problems encountered in manufacturing and quality
control.
• It is clear, therefore, that we are talking about
professionals who have had a practical as well as an
academic training.
• They should also continue to have training in their
area of expertise.
 Requirements for Key Personnel in GMP 6/7

• There are others who play an important role in the

operation of the factory, for example, engineers.
Engineers are crucial to the maintenance and operation of
the facility and equipment, in particular, for the processes
of planned preventative maintenance and validation.
Should possess 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 resolve the problems encountered
in manufacturing and QC
 Requirements for Key Personnel in
GMP 7/7
• Personnel should also possess appropriate
experience including practical experience in
the manufacture and quality assurance of
pharmaceutical products.
• It is common and recommended, that there
should be a preparatory period under
professional guidance for new employees.
Reviewing the Training for Personnel
in GMP 1/2
The following are the key points for reviewing training
for personnel in GMP
• 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
 Practical effectiveness checked
Reviewing the Training for Personnel
in GMP 2/2
• 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
END