What are the requirements?
Academic qualification (copy)
The personnel should have the education, training experience or combination of these elements that will allow them to effectively discharge their responsibility.
Operations records (copy)
Should describe the different operations which may affect the quality of the products or of the distribution activity.
Stock control records
Proper documentation of all stocks including damaged goods,returned goods, outward stock and inward stock.
Complaint's management system
All complaints should be forwarded through the right channels and must be addressed.
Storage conditions of goods and labels should be compatible. All pharmaceuticals should be stored off the floor. Special storage facilities for drugs that require special conditions should be present.
Mode of transport
Transportation of drugs should be hygienic and should be as per the labeling conditions.
Buildings and grounds
Should be secure, safe, well ventilated, hygienic have adequate lighting and should have a good waste disposal plan.
Measures in place to prevent the sale of counterfeit, expired drugs and unregistered drugs
These drugs must be separated from the rest to avoid confusion and selling of harmful drugs to traders.
Of the owner or a representative.
The time taken to carry out inspection depends on the size of the premises.
Attention at counter:
- Max. 1h.
Waiting time until next step:
Min. 1 day
- Max. 5 days
Guidelines for good distribution practices for phamarceuticals
The Pharmacy and Poisons Act CAP 244
Sections 23, 27
The applicant, together with the inspector, will be required to sign on the inspection findings.