SOP for Pharmacy in Kenya (Free PDF Download)

Pharmacy SOP for Kenya (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Kenya — covering Pharmacy and Poisons Board (PPB) licensing, Good Pharmacy Practice (GPP) standards, premises requirements, recall handling and inspections. Adapt the bracketed fields to your premises and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage, recall and inspection-readiness procedures required to operate a retail pharmacy in Kenya in line with PPB regulations and GPP guidelines.

2. Scope

Applies to the superintendent, all pharmaceutical staff and support personnel at [Pharmacy Name], [Address].

3. Regulatory Background

• The Pharmacy and Poisons Board (PPB) regulates pharmacy premises and professional practice in Kenya.
• Operations should follow the Good Pharmacy Practice (GPP) guidelines.
• The superintendent must be a registered pharmacist or pharmaceutical technologist, and may superintend only one premise.
• Premises registration costs Sh10,000; the annual practice licence is Sh5,000.
• A written SOP for recalls is required.
• Applications and renewals run through the PPB online portal at practice.pharmacyboardkenya.org.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Secure premises meeting PPB structural and GPP layout requirements (dispensary, storage, counselling area).
2. Appoint a superintendent — a registered pharmacist or pharmaceutical technologist superintending no other premise.
3. Register the premises with the PPB (Sh10,000) and obtain the annual practice licence (Sh5,000/year) via practice.pharmacyboardkenya.org.
4. Display current licences where inspectors and patients can see them.

5.2 Procurement

1. Purchase only from PPB-licensed wholesalers and distributors.
2. Verify product registration status and check batch numbers and expiry dates on receipt.
3. Quarantine any damaged, suspect or short-dated stock immediately.

5.3 Storage and cold chain

1. Store per label conditions; keep fridge temperature logs twice daily for cold-chain items.
2. Segregate expired, damaged and recalled stock in a marked quarantine area — never on sale shelves.

5.4 Dispensing

1. A qualified professional must verify every prescription before dispensing.
2. Counsel patients on dose, duration, storage and what to do about side effects.
3. Maintain a prescription register with full traceability.

5.5 Recall procedure

1. Maintain batch-level records linking every unit from supplier to patient.
2. On any recall trigger, the superintendent activates this SOP at once: identify affected batches, quarantine all units, and notify the PPB as required.
3. Contact patients/customers where the recall notice requires it; process returns and replacements.
4. File a complete recall report: batches, quantities found, quantities returned, notifications made.

5.6 Inspection readiness

1. Keep licences, registers, temperature logs, purchase invoices and the recall SOP filed and retrievable.
2. Ensure the superintendent (or a designated deputy) is present or reachable during inspections.

6. Pro Tips

• One premise per superintendent. The PPB enforces this strictly — sharing a superintendent across two shops risks both licences.
• Renew before expiry. Calendar the Sh5,000 practice licence renewal; operating on an expired licence is one of the commonest inspection failures.
• Use the portal. practice.pharmacyboardkenya.org handles applications and renewals — paper chasing through offices is slower and leaves no audit trail.
• GPP is the inspection yardstick. Layout, counselling space and record discipline are judged against Good Pharmacy Practice, so design the shop around it from day one.
• Batch traceability is non-negotiable. Without supplier-to-patient batch records, a recall becomes guesswork.

7. Frequently Asked Questions

Q1: Who regulates pharmacies in Kenya? A: The Pharmacy and Poisons Board (PPB), which handles premises registration, practice licensing and enforcement.

Q2: What does it cost to license a pharmacy? A: Premises registration is Sh10,000 and the annual practice licence is Sh5,000, processed through the PPB online portal.

Q3: Who can be a superintendent? A: A registered pharmacist or pharmaceutical technologist — and they may superintend only one premise at a time.

Q4: Is a recall SOP required? A: Yes. A written recall procedure with batch-level traceability from supplier to patient is required.

Q5: What is GPP? A: Good Pharmacy Practice — the PPB's guidelines covering premises layout, staffing, dispensing standards, counselling and recordkeeping. Inspections are assessed against it.

Q6: Where do I apply for licences? A: Through the PPB online portal at practice.pharmacyboardkenya.org.