Pharmaceutical Manufacturing Premises
REGISTRATION AND LICENSING
Procedures and Guidelines
Drug distribution channel is the channel (pathway) through which a drug product moves from the manufacturer and/or importer to the end users. This pathway not only helps in the product tracking, it also helps to monitor and guarantee the product quality, integrity and safety of its use by the end users.
Healthcare services in Nigeria and the world over largely hinge on availability of and access to medicines that are affordable, efficacious, safe, and of good quality.
Same as registration requirement for retail, distribution and importation outfit and shall also include:
- List of products to be manufactured;
- List of staff qualifications and duties;
- Factory layout;
- Production flow chart;
- List of equipment in production and quality control department;
- Source and water treatment facilities
- Water analysis report of raw and treated water;
- List and source of suppliers of raw materials and packaging materials;
- Standard Operating Procedures (SOP);
- Standard Cleaning Procedures;
- Inspection fees-Draft of N30,000.00 payable to the Pharmacists Council of Nigeria
Note: All Correspondences with the Council must be on the Company’s letter head paper.
On receipt of the above named documents, inspection of the above pharmaceutical premises shall be carried out to ensure compliance with the regulation requirements for the registration of such premises.
Also note that the National Agency for Food and Drugs Administration and Control (NAFDAC) has a complementary role to play in this registration.
6. Requirements for Registration of premises in Coordinated Wholesale Centres
- There shall be personnel for Quality Assurance
- There shall be personnel for Inventory Management
b. Storage Facility
- Each storage area should have a minimum area of 70 sqm inclusive of other office apartments
- Minimum Height shall be 3.05 meters
- There shall be a Loading bay/Delivery bay in the centre.
- There shall be at least one quarantine area in the centre
c. Good Storage Practice
- Products shall be properly demarcated.
- There shall be Standard Operating Procedures (SOP)
- There shall be:
- Systems to ensure adequate cooling
- Appropriate cold rooms/refrigerators thermolabile products
- Plastic/treated wooden pallets and metallic racks
- for the storage area
- Temperature and relative humidity logs and log recording equipment
- Good lightening system
- Dust free flooring
- IT enabled inventory management system
- A well dedicated and secured area for controlled substances
- A separate and dedicated area for rejects and returned products as well as retention samples
- Adequate material handling equipment
- Rodent and Insect trappers.