DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)At least 12 months of real time data and 6 months of accelerated data onat least three primary batches of the API ;The batches should be at least pilot scale-sized and manufactured by amethod that simulates the final commercial process.* In view of this, the re-test date may be extended beyond the end of realtime studies which can be extrapolated not more than 12 months coveredby the real time data.8.3. Where the API is sourced from multiple sites, stability data from each siteshould be provided.8.4. The NPCB may request for additional stability data if deemed necessary forthe evaluation of the application.8.5. Stability data is not required where the CEP specifies a re-test period that isthe same as or of longer duration than the re-test period proposed by theapplicant.9. SITE INSPECTION9.1. Depending on the outcome of the evaluation of the API dossier, a risk-basedapproach will be used in the planning of inspections; the approach will takeinto account the type of APIs as well as the outcome, results and reports ofinspections conducted by other regulatory authorities or competentorganizations.9.2. The NPCB shall plan and coordinate the performance of inspections at themanufacturing site(s) of the APIs and that of the key intermediate (ifrelevant) to assess compliance with the relevant sections of the relevantGMP Guidelines, and will compare the technical information on themanufacturing process given in the API dossier shall be compared with themanufacturing process actually carried out on the manufacturing site.9.3. All such inspections shall be performed by inspectors deemed to possesssufficient qualifications and experience in order to perform such inspections,to be competent in areas such as production and quality control ofpharmaceuticals, and have appropriate experience in the area of GMP.Such inspectors shall perform the inspections and report on its findings inaccordance with established Standard Operating Procedures (SOPs) so asto ensure a standard harmonized approach.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 324
Drug Registration Guidance Document (<strong>DRGD</strong>)10. MAINTENANCE OF APPROVAL STATUS10.1. Manufacturers of finished products should establish a mechanism by whichmanufacturers/ suppliers of an API shall provide information on any changes(i.e., variations) in manufacture and control that may have impact on thesafety, purity and quality of the API. It is the PRH‟s responsibility to providethe NPCB with the appropriate documentation (referring to relevant parts ofthe dossier) to prove that any intended or implemented variation will nothave an impact on the safety, purity and quality of the API that has beenpreviously approved. For those APIs approved by the NPCB, an evaluationof such variations shall be performed with accordance to the ASEANVariation Guidelines.10.2. Random samples of APIs supplied to manufacturers of finishedpharmaceutical products may be taken for independent testing if there is aneed. Certificates of Analysis released by the API manufacturer as well asspecifications for test methods shall be provided by the API manufacturer orthe PRH to the NPCB for review upon request. In the event of failure to meetthe established criteria for testing, the NPCB shall proceed to investigateand communicate this problem to the manufacturer concerned.10.3. The NPCB may conduct a re-evaluation of the APIs at a 5 year interval. If,as a result of this re-evaluation, it is found that an API and/or specifiedmanufacturing site(s) no longer complies with the recommended standards,such APIs and manufacturing sites will be removed from the approved list.Prior notice to the PRH and API manufacturer shall be issued from theNPCB regarding such decision.10.4. Re-evaluation may also be done in any situation deemed necessary,including the following:If any omissions by the manufacturer in the initial assessment procedureor during the follow-up activities is evident in relation to the requirements.This includes compliance with GMP.If any batch(s) of supplied APIs is considered not to be in compliancewith the agreed specification of the API;If the CEP, or an API for which a CEP dossier was submitted, iscancelled or refused based on the assessment of the dossier for anyother reason; and,National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 325
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PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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