DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)5.11. API Manufacturer is responsible to maintain and update the DMF. ThePRH should file a variation once they are notified with the changes to theDMF.5.12. API Manufacturer Obligations:Any change or addition, including a change in authorization related tospecific PRH, shall be submitted to the NPCB in duplicate andadequately cross-referenced to previous submission(s). The referenceshould include the date(s), volume(s), section(s), and/or pagenumber(s) affected.Should any change to a DMF is necessary, the API Manufacturer shallnotify each affected PRH who has referenced the DMF of the pertinentchange. Such notice should be provided well before making thechange in order to permit the PRH to supplement or amend anyaffected application(s) as needed.5.13. A DMF is not required for common inorganic salts (for example, sodiumchloride, and other common electrolytes) used and regarded as API inproducts such as injections and dialysis solutions, and simple organiccompounds available commercially in high purity (for example, naturaloccurring organic acids and their salts, including ascorbic acid and sodiumcitrate, and simple mono- and disaccharides such as glucose andsucrose). Although a DMF is not required for these active ingredients,evidence needs to be submitted by the finished PRH that the substance isobtained from a reliable source and consistently comply with theapplicable pharmacopoeial specifications. Any non-pharmacopoeialspecifications need to be assessed by the NPCB to determine theirappropriateness and adequacy to ensure the quality of the substance.5.14. Where a DMF is submitted for an API controlled according to apharmacopoeia monograph, the DMF should include a discussion of thepotential impurities most likely to arise during synthesis using the actualmanufacturing process described in the DMF together with evidence thatthese impurities are adequately controlled by the test proceduresdescribed in the pharmacopoeial monograph. Where particular impuritiesfound in the substance are not listed in the monograph, a justification(including toxicological data, if appropriate) should be provided. Details onthe principles for the control of impurities (e.g. reporting, identification andqualification) are outlined in the ICH Q3A, Q3B and Q3C guidelines.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 320
Drug Registration Guidance Document (<strong>DRGD</strong>)6. CERTIFICATES OF SUITABILITY (CEP)6.1. CEP stands for certification of suitability of European Pharmacopoeiamonographs/ Certificate of Pharmacopoeia.6.2. The CEP is a document that is used to demonstrate that the purity of a givensubstance produced by a given manufacturer is suitably controlled by therelevant monograph(s) of the European Pharmacopoeia. By demonstratinggrant a CEP for given API, the suppliers of the API can prove such suitabilityto their pharmaceutical industry clients and the NPCB.6.3. The PRH should include a copy of the most current CEP in the dossier,together with the following:A written assurance that no significant changes in the manufacturingmethods or processing have taken place following the granting of thecertificate or its last revision andA declaration from the API manufacturer that the local PRH and theNPCB shall be notified should there be any future change in the APIspecifications in the manufacturing process that is likely to affect theproduct‟s quality or safety.Note: All such written statements must state the name of the drug product(product name, dosage form and product strength) to be registeredand the local PRH responsible for finished product registration.6.4 If reference is made to a CEP, the PRH should submit a copy of the validCEP, including all annexes, in lieu of a DMF.Along with the CEP, the applicant should supply the following information inthe product dossier.• 3.2.S.1.3 General properties - discussions on any additionalapplicable physicochemical and other relevant API properties that arenot controlled by the CEP and Ph.Eur. monograph, e.g. solubilitiesand polymorphs as per guidance in this section.• 3.2.S.3.1 Elucidation of structure and other characteristics -studies to identify polymorphs (exception: where the CEP specifies apolymorphic form) and particle size distribution, where applicable, asper guidance in this section.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 321
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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