DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)17. Shelf LifeShelf life for all the listed pack types shall be supported by stability data.Information include shelf life before first opening, after reconstitutionand/or after opening where applicable shall also be provided. Stability datato support such shelf life shall be submitted.Evidence is required to demonstrate that the product is stable which meetsthe finished product shelf life specifications throughout its proposed shelflifeand toxic decomposition products are not produced in significantamounts during this period; potency, sterility and efficacy of preservative,etc. are maintained.18. Therapeutic CodePlease indicate WHO assigned ATC code for each distinct therapeuticindication proposed for a product, if such a code is available. Click button„click here to search‟ to search the code via database athttp://www.whocc.no/atcddd/.For natural products, please select “Traditional/ Homeopathy” from thelisted button.After completion of Section A has been done, please click Section List for display ofmain page of application form and select Section B: Product Formula, or click button„next‟ after saving the entered data.SECTION B: PRODUCT FORMULAa) For full evaluation requirement, B1.1 and B1.2 as described below is requiredunder Section B: Product Formula. Data pertaining to quality of product isrequired to be submitted under Part II: Quality of Product.B1.1 Batch Manufacturing FormulaPlease state batch size and actual batch manufacturing masterformula.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 448
Drug Registration Guidance Document (<strong>DRGD</strong>)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
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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