DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)Step II:27. Importer (if any)28.Other manufacturer(s) involved, e.g. repacker (if any)(Please attach Certificate of GMP, if yes)29. Store AddressPART II: QUALITY OF PRODUCTNo.Section P: Drug Product (Finished Product)1. Description and Composition2. Pharmaceutical Developmenta) Information on Development Studiesb) Components of the Drug Productc) Finished Productsd) Manufacturing Process Developmente) Container Closure Systemf) Microbiological Attributesg) Compatibility3. Manufacturera) Batch Manufacturing Formulab) Manufacturing Process and Process Controlsc) Manufacturing Process Flowchartd) Control of Critical Steps & Intermediatese) Process Validation and/or Evaluation4. Control of Excipientsa) Specificationsb) Analytical Proceduresc) Validation of Analytical Proceduresd) Justification of Specificationse) Excipient of Human or Animal OriginNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 139