SUBMISSION OF PRODUCTS
- The client shall submit Samples (Using the Sampling guide) for Quality Control Test of Product with a manifest (the list of samples i.e. the names with the batch number, manufacturing and expiry date)accompanied with test request form (A Form in which the client indicates the analysis they want carried out on their product)
- The Applicant shall submit Dossier in CTD format for Drugs and Certificate of Analysis for Biologics, Cosmetics, Medical Devices.
- The samples shall have at least 6 months before expiry.
- The client shall be notified in writing within 72 hours if the product(s) are rejected.
- REASONS FOR REJECTION
- Insufficient quantity of sample
- Leaking sample
- Broken seal
- Different pack size/batch No/packaging or literature insert for one sample
- Obviously damaged sample. top
- Samples shall be tested according to Official monographs (USP, BP, INT’L Pharmacopeia) or with the manufacturer’s validated method and other additional tests as in the laboratory Quality Manual.
- Analysis shall be completed within 6weeks (Drugs) and 8 weeks for Biologics. top
TRANSMISSION OF RESULT
- The result shall be issued directly to the client either electronically or otherwise as required by the client and are kept confidential.
- Out of Specification results shall be reported to clients. However, investigation reports are confidential documents and would not be shared. top
GUIDELINES FOR LOT RELEASE OF VACCINES
- There shall be a formal notification to Agency two (2) weeks before the arrival of the vaccines in Nigeria.
- Product(s) shall be accompanied with three (3) critical documents: Lot release certificate from country of origin, Certificate of analysis and Summary Lot Protocol for production and finished product.
- Inspection and Sampling shall be carried by the Agency on arrival of product(s) at the port of Entry or at the importer cold storage facility.
- The product(s) shall be place on hold until lot release process is completed.
- Laboratory testing and lot release shall take a maximum of four (4) weeks. top