DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)• S2 Manufacture2.1 Manufacture(s)/ Site of Manufacture2.2 Description of Manufacturing Process and ProcessControls2.3 Control of Materials2.4 Controls of Critical Steps and intermediates2.5 Process Validation and/or Evaluation2.6 Manufacturing Process Developmento An original Letter of Access (see below).The Letter of Access authorizes the NPCB to refer to the DMF, insupport of the application for a drug product. Thus, the Letter ofAccess must state the following:The name of the drug product (product name, dosage form andproduct strength) to be registered;The local PRH responsible for finished product registration; and,A declaration that both the local PRH and the NPCB shall benotified of any change in the API specification or in themanufacturing process that will likely affect the product‟s qualityor safety.It is the responsibility of the applicant to ensure that the completeDMF (i.e. both the applicant‟s Open part and the API manufacturer'sclosed part) is supplied to NPCB directly by the API manufacturerand that the applicant has access to the relevant information in theDMF concerning the current manufacture of the API.5.9. The API Manufacturer may submit the DMF via electronic copy (CD) orhardcopy (optional) directly to the NPCB to maintain confidentiality of thecontents. The information contained in the restricted part of the DMF willbe regarded as confidential and will only be evaluated in support of theapplications mentioned in the Letter of Access. The confidentialinformation will not be disclosed to any third party without a writtenauthorization from the API Manufacturer.5.10. Upon receipt of the DMF, a BPFK DMF number will be assigned to theapplication for product registration. For future correspondences, the PRHand the API Manufacture should make a reference to this assigned BPFKDMF number. Should there be deficiencies within the restricted part of theDMF; The NPCB will raise queries directly with the API Manufacturer. ThePRH referencing a DMF is required to include a copy of the APIManufacturer‟s Letter of Access in the application.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 319