DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)Step II:f) Novel Excipients5. Control of Finished Productsa) Specificationsb) Analytical Proceduresc) Validation of Analytical Proceduresd) Batch Analysese) Characterization of impuritiesf) Justification of Specifications6. Reference Standards or Materials7. Container Closure System8. Stability9.No.Product Interchangeability/ Equivalent Evidence (Bioavailability/Bioequivalence, BA/BE)- Please refer 2.1.3 Additional information on requirements of BA andBE.Section S: Drug Substance1. General Informationa) Nomenclatureb) Structure and Attachment for Structure of Drug Substancec) General Properties2. Manufacturera) Manufacturer Name and Addressb) Description of Manufacturing Process and Process Controlsc) Controls of Materialsd) Controls of Critical Steps and Intermediatese) Process Validation and/or Evaluationf) Manufacturing Process DevelopmentNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 143