GMP -Personnel requirements
Session 3: GMP -Personnel requirements
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
35 minutes Presentation General Possible Issues Related to Personnel
2
Buzzing in GMP
30 minutes General Principles Related to Personnel in
3 Presentation
GMP
30 minutes Presentation
4 Requirements for Key Personnel in GMP
Brainstorming
5 10 minutes Presentation Reviewing the Training for Personnel in GMP
6 05 minutes Presentation Key Points
7 05 minutes Presentation Evaluation
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: General Possible Issues Related to Personnel in GMP ( 35
minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 2 minutes
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
o In a company 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.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
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.
STEP 3: General Principles Related to Personnel in GMP ( 30 minutes)
The following are principles related to personnel in GMP:
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.
meet the requirements.
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.
at the time of recruitment with a regular check on a periodic basis afterwards.
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.
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.
cannot cope, resulting in a risk to quality of the product.
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.
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
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
enterprises. They arise because of a combination of human interactions, and the pressures
placed on people by the business considerations
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.
and maintenance of high quality standards in all work performed.
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 (see Premises).
STEP 4: Requirements for Key Personnel in GMP (30 minutes)
Activity: Brainstorming (5 minutes)
ASK students to brainstorm on the following question:
ALLOW few students to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
o The heads of production,
o Quality control personnel
o Sales and distribution personnel
o Authorized person who releases product for sale
both report to a technical director) but may share certain responsibilities.
responsibility cannot be delegated.
chemistry or biochemistry
chemical engineering
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
microbiology
pharmaceutical sciences and technology
pharmacology and toxicology
physiology; or
other related science subjects relevant to the responsibilities to be undertaken
personnel and it goes into a lot of detail.
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.
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.
academic training.
Engineers are crucial to the maintenance and operation of the facility and equipment, in particular,
for the processes of planned preventative maintenance and validation.
o Practical experience
o Manufacture and quality assurance
o Preparatory period under professional guidance sometimes needed
o 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
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.
professional and scientific way, and to resolve the problems encountered in manufacturing and
QC.
STEP 5: Reviewing the Training for Personnel in GMP (10 minutes)
The following are the key points for reviewing training for personnel in GMP
and For others whose activities could affect the quality of the product including technical,
maintenance and cleaning personnel
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o On theory and practice of GMP and their duties
o Training records should be kept
o Practical effectiveness checked
o Training before undertaking any new task
Including clean areas; or Areas where highly active, toxic, infectious, sensitizing materials
are handled
understanding to ensure its implementation
STEP 6: Key points (5 minutes)
aware of GMP, personnel must receive training and have appropriate qualification
control
STEP 7: Evaluation (5 minutes)
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
References
Signore, A. A., & Jacobs, T. (2017). Good design practices for GMP pharmaceutical
facilities. Boca Raton, Fl.: CRC Press.
Lund, W. (2009). The pharmaceutical codex: Principles and practice of pharmaceutics. New
Delhi: CBS.
Aulton, M. E., & Taylor, K. (2018). Aulton s pharmaceutics: The design and manufacture of
medicines. Edinburgh: Elsevier.
Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, 8th Ed. Baillie're Tindall.
London
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
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