DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)Data from validation step will be captured in terms of substance name,type (active or excipient ingredient), function and quantity per unitdose.Other information such as overage (where applicable) shall be entered.B1.2 Attachment of the Batch Manufacturing Formula DocumentationThe attachment shall be submitted.b) For abridged evaluation requirement, Batch Manufacturing Formula is requiredunder B1.1 and Attachment of the Batch Manufacturing Formula documentationis required under B4 of the same section i.e. Section B.Whereas B2.1, B3, B4 and B5 appear as below:B2.1 Manufacturing processPlease state a brief description of the manufacturing process.Essential points of each stage of manufacturing process and adescription of the assembling of the product into final containers shallbe covered. If the product is repacked/ assembled by anothermanufacturer, details of repacking/assembly and quality control shallbe supplied.An attachment of the manufacturing process, in the form of a flowchart can be submitted under B2.2.B3. In-Process Quality ControlPlease attach document for In-Process Quality Control to provide asummary of the tests performed, stages at which they are done, andthe frequency of sampling and number of samples taken each time.Specifications for quality assurance of the product shall be supplied.B4. Attachment of Finished Product Specification DocumentationPlease attach document for Finished Product Specification to providedetails of quality control specifications, including a list of tests for bothrelease and shelf life specifications (if they are different); and state thelimits of acceptance.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 449