DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)• 3.2.S.4.1 Specification - the specifications of the FPP manufacturerincluding all tests and limits of the CEP and Ph.Eur. monograph andany additional tests and acceptance criteria that are not controlled inthe CEP and Ph.Eur. monograph, such as polymorphs and/or particlesize distribution.• 3.2.S.4.2/ S.4.3 Analytical procedures and validation – for anymethods used by the FPP manufacturer in addition to those in theCEP and Ph.Eur. monograph.• 3.2.S.4.4 Batch analysis - results from two batches of at least pilotscale, demonstrating compliance with Ph. Eur. monograph andincluding any additional tests/ limits listed on the CEP (e.g. residualsolvents, additional impurity tests) or the product manufacturer‟s APIspecifications.* In cases where the drug product manufacturer tests the CEPcertified API according to specification other than Ph.Eur. (i.e.USP, JP, In-House etc.) data covering S 4.1 to S4.5 should besubmitted by the PRH.• 3.2.S.5 Reference standards or materials – information on the FPPManufacturer‟s reference standards.• 3.2.S.6 Container closure system - specifications includingdescriptions and identification of primary packaging components.Exception: where the CEP specifies a container closure system andthe applicant declares to use the same container closure system.• 3.2.S.7 Stability - exception: where the CEP specifies a re-testperiod that is the same as or of longer duration, and storageconditions which are the same or higher temperature and humidity asproposed by the applicant.In the case of sterile APIs, data on the sterilization process of the API,including validation data, should be included in the PD.6.5 The NPCB reserves the right to request for any additional information aboutthe API when deemed appropriate.6.6 . The PRH‟s responsibility to submit the latest CEP updates, with annexes, assoon as it is available from the API manufacturer.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 322
Drug Registration Guidance Document (<strong>DRGD</strong>)7. FULL DETAILS OF API INFORMATION IN THE PRODUCTDOSSIER APPLICATION7.1. Information on the Active pharmaceutical ingredient sections (ACTD Part IIS), including full details of chemistry, manufacturing process, quality controlsduring manufacturing and process validation for the API, should besubmitted in the product dossier.7.2. The ICH M4Q Technical Guideline and ASEAN Common TechnicalRequirements (ACTR) provide details on the information to be included inthe API sections of an application dossier.7.3. If drug product contains more than one API, the information within Part II S(ACTD) must be provided for each API.7.4. Where the drug substance and the drug product are manufactured by thesame company, information on the production, quality control and stability ofthe drug substance may be submitted as part of the dossier for the drugproduct (ACTD) rather than in a separate DMF. However, the company isnot precluded from submitting a DMF for the drug substance if it prefers todo so.8. STABILITY DATA OF API8.1. Stability test data for an API should be provided, for at least 3 primarybatches. These data should include:Batch details (e.g., batch number, date of manufacture, batch size, useof batch);The general test methodology (e.g., duration of study, storage conditionsof temperature and humidity, time points when samples were removedfor analysis etc.);The analytical test methods (e.g., assay method of quantitation,determination of degradation products, moisture etc);Validation of test methods;Results of tests; and,Conclusions.8.2. In circumstances where an API retest period has not been established andcomplete real time stability data is not available at the time of submission,the minimum stability data required are as follows:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 323
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PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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