Industrial Pharmacy Practice Notes-1

Industrial Pharmacy Practice
Relevant legislation
-The Pharmacy and Poisons Act Cap.244
- Anyone wanting to manufacture a medicinal product,

must have a license from the PPB.
- The premises on which the product is manufactured
must also be registered and licensed by the board
- National Quality Control Laboratory

The board assigns them to:
- Examine and test drugs/any material or substance
- Perform chemical, biological, pharmacological,
physiological tests and pharmaceutical evaluations
- Test at the request of the board
The board assigns a board of management that consist of 9
members. They are required to meet at least 4 times a year,
and have a quorum of more than 5.
The director is usually the secretary of the board of
management and may regulate its own procedure.
The functions of the board of management are:

- To administer the property and funds of the lab
- To receive grants and donations
- To make regulations governing appointment, conduct
and discipline employees
- To approve T&Cs
- To appoint employees
A certificate of analysis is always provided and approved by
the Director for any tests conducted.
- Any product license and premise license expires on 31 st

December of each year. These must be renewed
annually.
Development of Sterile and non-sterile products
Manufacture of Sterile Products:
Four grades of clean area:

1. Grade A: high-risk operations e.g. filling and making
aseptic connections. A unidirectional airflow
workstation should be used. Airflow visualisation tests
should be carried our to demonstrate uniformity and
effectiveness of the unidirectional airflow
2. Grade B: Used in aseptic production and filling
3. Grade C and D: Clean areas for carrying out less critical
procedures,
HEPA filters should be checked for leaks every 6 months.
Conducting Clinical Trials:

- An application to the PPB must be made.
- The principal investigator of the clinical trial must be a
resident of Kenya. Pharmacists, dentists or medical
doctors in the trial must be registered with respective
boards in Kenya
- All investigators must have had GCP training in the last
3 years, otherwise must be trained before starting
- SOPs must be drawn up for all procedures to be done.
- All ADRs and AEs must be reported to PPB
- If trial is terminated/suspended PPB must be informed
and give reasons, the report should be submitted within
15 days
- When study is completed, a preliminary report must be
submitted to PPB within 30 days, and the final report in
180 days
Phase 1 clinical trial: non-clinical aspects
Licensing of Products
- This is to be down for products to be used in the Kenyan
market
- A separate application must be made for each product
that differs in strength, form, API. One application can
be given for the same product but different pack size.
- A summary of recommendations of evaluation, lab
analysis and GMP status reports will be presented to a
Committee of Drug registration for consideration and
they reject or approve the product.
- If the board approves according to cap 244, a marketing
authorisation will be given.
- Pharmaceutical products that are registered are valid
for 5 years, unless suspended or revoked
Pharmaceutical Marketing
- Any advertisement being made for a pharmaceutical
product must have clearing and authorisation by the
PPB
- The adverts must not be misleading, claim to be better
than another, not show children using the medication,
unbiased, endorse KMA, PSK etc., no offers and samples
should be given
- An advertisement should not refer to an Act or any
department or official of the Board
- Any medication for the following cannot be advertised:
1. Cure of amenorrhea, STIs, HIV/AIDs
2. The cure of any habit associated with sexual
indulgence or ailments associated with this, or the
restoration or stimulation of the sexual functions
3. The prevention, relief or cure of blindness, bright’s
disease, schistosomiasis, cancer and malignancies
4. The cure of alcoholism, appendicitis,
arteriosclerosis, bladder stones, cardiovascular
disease, cataract, diabetes, diphtheria, dropsy,
epilepsy, gallstones, gangrene, glaucoma, goitre,
heart disease hernia, hyper/hypotension, infantile
diarrhoea, kidney stone, leprosy, ataxia, lupus,
meningitis, MS, osteoarthritis, Parkinson’s, polio,
pneumonia, RA, tetanus, TB
5. Use of medicines to add or lose weight or alter
bodily functions apart from those scientifically
proven.
POMs can only be advertised on websites whose nature and

content are directed to health professionals
Adverts to general public should only be GSL- must state that
any symptoms, consult doctor.
Responsibilities of Qualified person

- Authorisation of written procedures and other
documents, including amendments
- Monitoring and control of the manufacturing
environment
- Plant hygiene
- Process validation and calibration of analytical
apparatus
- Training, including application and principles of quality
assurance
- Approval and monitoring of supplier materials
- Approval and monitoring of contract manufacturers
- Designation and monitoring and storage conditions for
materials and products
- Performance and evaluation of in-process controls
- Retention of records
- Monitoring of compliance with GMP requirements
- Inspection, investigation and taking of samples in order
to monitor factors that may affect product quality

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Industrial Pharmacy Practice

-The Pharmacy and Poisons Act Cap.244

- Anyone wanting to manufacture a medicinal product,

- National Quality Control Laboratory

The functions of the board of management are:

- Any product license and premise license expires on 31 st

Development of Sterile and non-sterile products

Manufacture of Sterile Products:

Four grades of clean area:

Conducting Clinical Trials:

Phase 1 clinical trial: non-clinical aspects

POMs can only be advertised on websites whose nature and

Responsibilities of Qualified person

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