SOP for Pharmacy in Gambia (Free PDF Download)

Pharmacy SOP for Gambia (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in The Gambia — covering Medicines Control Agency (MCA) and Pharmacy Council of The Gambia (PCG) licensing, mandatory pharmacist staffing and supervision rules, procurement, dispensing, recall handling and pharmacovigilance. 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 recordkeeping procedures required to operate a retail pharmacy in The Gambia in line with the Medicines and Allied Substances Act 2013 and the MCA and Pharmacy Council guidelines.

2. Scope

Applies to the supervising pharmacist, all pharmacists, pharmacy technicians and dispensing assistants at [Pharmacy Name], [Address].

3. Regulatory Background

• The Medicines Control Agency (MCA) regulates medicines and related products; the Pharmacy Council of The Gambia (PCG) regulates pharmaceutical personnel and premises licensing.
• Under the Medicines and Allied Substances Act 2013, a certificate of registration is issued within 60 days of a complete application if the premises are suitable, the pharmacy is under the management and control of a registered pharmacist at all times, and no law is contravened.
• A retail pharmacy's minimum staffing is: 1 pharmacist, 2 pharmacy technicians/nurse dispensers and 2 dispensing assistants.
• Supervision rules: a retail pharmacy operating 14 hours or more must have pharmacist supervision of at least 4 hours per day; one pharmacist may supervise no more than one wholesale and two retail pharmacies at a time.
• The registration certificate must be displayed conspicuously at the place of business, and holders must file an annual return with the Agency on payment of the prescribed fee.
• Pharmacovigilance operates under the MCA's safety-monitoring guideline, with a Qualified Person Responsible for Pharmacovigilance (QPPV) framework for marketed products.
• Confirm current fees, staffing tables and application forms with the MCA and the Pharmacy Council before opening, as guidelines are updated periodically.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the business and secure premises that meet MCA premises standards.
2. Appoint the supervising pharmacist — a pharmacist registered with the Pharmacy Council, able to meet the 4-hours-per-day supervision minimum.
3. Submit the MCA certificate-of-registration application with all prescribed documents; the Agency inspects the premises before issuance.
4. Display the certificate of registration conspicuously at the place of business.
5. File the annual return with the Agency on payment of the prescribed fee.

5.2 Procurement

1. Source medicines only from MCA-licensed suppliers and verify product registration.
2. Check expiry dates, batch numbers and physical condition on receipt; quarantine anything suspect.

5.3 Storage

1. Store per label conditions; maintain the cold chain for thermolabile products with twice-daily temperature logs.
2. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Dispense only against valid prescriptions for prescription-only medicines, verified by a pharmacist.
2. Counsel every patient on dosage, duration and storage.
3. Record each dispensing in the prescription register.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (MCA, manufacturer or internal finding), the supervising pharmacist initiates the recall immediately.
3. Identify and quarantine all affected batches, notify patients where required, and return stock per the recall notice.
4. Document the entire recall: batches, quantities, notifications, returns.

5.6 Pharmacovigilance

1. Collect and forward every suspected adverse drug reaction to the Agency under its safety-monitoring guideline.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, purchase invoices, temperature logs, recall files and ADR reports for the period the Agency requires — confirm the current retention period with the MCA.
2. Make all records available to MCA inspectors on demand.

6. Pro Tips

• Plan the supervision roster first. The 4-hours-per-day pharmacist minimum for a 14+ hour retail pharmacy is a hard rule — build the rota before you open.
• Respect the two-retail-pharmacy cap. One pharmacist may supervise at most one wholesale and two retail pharmacies — sharing a supervisor beyond that breaches the guideline.
• Display the certificate. The Act requires conspicuous display — inspectors check this on entry.
• File the annual return on time. The certificate's annual return and fee keep the registration alive — diary it.
• Keep ADR forms at the counter. Reporting dies when the form is locked in an office — dispensers need it within arm's reach.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in The Gambia? A: The Medicines Control Agency (MCA) regulates medicines, while the Pharmacy Council of The Gambia regulates pharmaceutical personnel and premises licensing. Both bodies work together.

Q2: What staff must a retail pharmacy have? A: At minimum: 1 pharmacist, 2 pharmacy technicians/nurse dispensers and 2 dispensing assistants.

Q3: How many hours must a pharmacist supervise? A: A retail pharmacy operating 14 hours or more needs pharmacist supervision of at least 4 hours per day. One pharmacist may supervise no more than one wholesale and two retail pharmacies at a time.

Q4: How long does registration take? A: Under the Medicines and Allied Substances Act 2013, the certificate of registration is issued within 60 days of a complete application, provided the premises are suitable and the pharmacy is under a registered pharmacist's control at all times.

Q5: Must the certificate be displayed? A: Yes — the holder must display it in a conspicuous manner and place at the business, and file an annual return with the Agency on payment of the prescribed fee.

Q6: How are adverse drug reactions reported? A: Suspected adverse reactions are collected, processed and forwarded to the Agency under the MCA's safety-monitoring (pharmacovigilance) guideline, with a copy filed in the pharmacy's records.