DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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