SUMMARY FOR ISSUANCE OF CRIA FOR FINISHED PHARMACEUTICAL PRODUCTS (FPP)
AS OF SEPTEMBER 12, 2020 BY NAFDAC
As per new directives which are being placed by NAFDAC as of September 12, 2020 are for continuing improving the CRIA issuance process we request Indian manufacturer / exporter requesting for CRIA for FPP on www.silislabs.com as below :
- FPP will be analyzed as per official Pharmacopeial Monograph only i.e. as per USP / BP / Ph. Eur. / International Pharmacopoeia and if the FPP is not official in any Pharmacopoeia then In-house Testing Method used must conform to test & parameters as available in any of the above Pharmacopeial Monographs, which would become the basis for the analysis.
- Manufacturer / exporter has to provide approximately 5 grams of the sample of API (in securely packed condition) of same batch which is used in the manufacturing of that particular FPP batch;
- If in case two or more batches of API has been used in the manufacturing of a particular batch of FPP than all batches of the sample of API used in the production are to be provided (in securely packed condition) for analysis;
- Products with multi ingredients – manufacturer / exporter has to provide the sample of one of the main API & two micro API’s for the analysis used (as per label claim)
- Mandatory documents to be submitted :
- Self-attested copy of valid NAFDAC issued Product Registration Certificate
- Self-attested copy of valid Electronic NAFDAC Certificate
- Self-attested copy of valid COPP
- Self-attested copy of FORM M
- Pack Size Extension in case there is change in packing style other than the one mentioned in the NAFDAC issued Product Registration Certificate
- Self-attested copy of Manufacturing License as issued by the State FDA.
- Copy of Airway Bill or Bill of Lading
(All these above documents would become part of the CRIA issued, therefore Final Original CRIA would be issued once Airway Bill or Bill of Lading is received by our (SILIS LABS Pvt. Ltd., Ahmedabad office)
- Product can be dispatched ONLY to the Nigerian Company holding the Product Marketing Authorization Holder as mentioned in the NAFDAC issued Product Registration Certificate or any deviation has to be supported by NAFDAC issued Letter.
- Product cannot be manufactured / exported with same NAFDAC Product Registration Number in different colored monocartons or two or more different colored FPP.
- FPP has to be manufactured at the same site which has been approved by NAFDAC & is indicated in the NAFDAC issued Product Registration Certificate
As a relief from NAFDAC – DO NOT TO PUT ANY SAMPLE OF API used in manufacturing of FPP in the consignment.
NOTE : IF THE SAMPLE OF API FAILS IN ANALYSIS AND THE FPP PASSES THE ANALYSIS OR VICE VERSA THE SAMPLE / BATCH OF THE FPP WOULD BE CONSIDERERD FAILING ANALYSIS & THE LABORATORY DIRECTLY REPORTS THIS TO THE CRIA DESK.
In case of any clarification or doubts feel free to contact NAFDAC Officials at :
CONSIGNMENT IS NOT TO BE DISPATCHED TILL ONE RECEIVES PROVISIONAL CRIA OVER MAIL OR OTHERWISE IT WOULD BE CONSIDERED VIOLATION BY NAFDAC