Locally-NAFDAC Registration
Accreditations
NAFDAC REGULATIONS
“This Regulation law prohibits the sale of counterfeit, fake drugs and unwholesome processed foods. The Law also prohibits the sale and distribution of counterfeit, adulterated, banned, substandard or expired drugs. This law is promulgated to prohibit the sale of certain foods, drugs, cosmetics and devices. Therefore, all regulatory products must be registered,.”
Timeline
Submission of application – 0 days
Document verification – 10 days
Facility inspection/sampling – 10 days for food, 20 days for drugs
Laboratory analysis – 30 days for food, 40 days for drugs
Final vetting – 10 days
Approval meeting/issuance of NAFDAC registration number(certificate of registration) – 20 days
Total number of days: 90 days for food, 120 days for drugs
Enquiry
BUILDINGS AND FACILITIES
There should be defined areas of adequate size to accommodate the different operations in a logical order of production flow corresponding to the sequence of the operations.
The operational areas should include;
- 1. Cloakroom.
- 2. Toilet facilities (which should not open directly into the production area)
- 3. Raw Materials Store
- 4. Packaging Materials Store
- 5. Production section.
- 6. Finished Products Store
- 7. Laboratory (optional)
ORGANIZATION AND PERSONNEL
There should be an adequate organizational structure that clearly defines names and qualifications of key personnel.
There should be adequate number of qualified personnel to perform and supervise the various processes.
In-house and in-process Quality Control of functions may be carried out by the production manager while comprehensive/detailed product analysis should be performed by a public analyst registered by the Institute of Public Analysts of Nigeria (IPAN).
There should be adequate general and specific training for employees and should be conducted regularly by qualified individuals.
The quality control and production units shall be distinct and independent units that function and report directly to the management.
Personnel should wear clean protective apparels such as hand gloves, head covering, nose and mouth mask to protect products from contamination.
Personnel should practice good sanitation and hygienic habits. Eating, drinking, chewing and smoking in the production and storage areas should be prohibited.
All personnel should have access to medical treatment and checks for communicable diseases and the records should be kept.
Any person shown at any time to have apparent illness or open lesions that may adversely affect the safety or quality of product should be excluded from direct contact with the product until the condition is corrected. All personnel should be instructed to report any health conditions that may have adverse effect on the production of the product.
REQUIREMENTS FOR PRE-PACKAGED FOOD/COSMENTICS MANUFACTURING/PACKAGING FACILITY IN NIGERIA
BUILDINGS AND FACILITIES
The facility for the production of food products should be purpose-built or suitably adapted to comprise a minimum of four rooms designated as
- the cloak room,
- packaging material store,
- production section
- finished product store.
- (For small scale) a room or kitchen for micro scale products