DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Example of In Process Quality Control:Company Name/ Address:Applicant/ Client Name/ Address:Date:In-Process Quality Control: Test performed during manufacturing processNo.Test Done(example)Stage Done(example)Frequencyof testing(example)Quantitysampletaken(example)Specifications(example)Method(example)1. AppearanceBeforeweight, afterencapsulation2 10 gramBlue likeorangeOrganoleptictest2. DisintegrationAftercompression2 10 tabletNMT 30minutesEquipmentetc3.Uniformity ofweightAftertableting,Packaging4 20 Tablets 1 gram/tab4. Microbiology Final Stage 15. Heavy metal Final stage 1* Declaration (if any)Signature (authorized personnel)Name:Designation:* The above parameters are only as an example; other test may be required for specificproduct.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 196
Drug Registration Guidance Document (DRGD)Finished Product Quality SpecificationProvide details of quality control specifications including a list of tests for both releaseand shelf life specifications (if they are different) and state the limits of acceptance.Example of Finished Product Quality SpecificationFinished Product Quality Control (FPQC) - Finished product Specification/Specification SheetCompany name/Address:Product Name:Batch no.Dosage form:Packaging:Date of manufacture:Date of expiry:No. Test Method Specification Reference1.2.Appearance/Organoleptic:OdourColourAssay:List the active ingredientsEx:Macroscopic/MicroscopicHPLC/ GC/MS/ UVTo describethecharacteristicTo specifyIn-house/pharmacopoeia(e.g. BP/USP etc)To specify3. Disintegration/Dissolution To specify DRGD DRGD4. Uniformity of weight To specify5. Water content To specify6.7.8. Etc:Microbial contaminationTAMC, TYMC, specifiedmicroorganismHeavy MetalContamination:Lead, Arsenic, Cadmium,MercuryTo specify DRGD DRGDTo specify DRGD DRGDSignature:Name:Designation: (At least by Quality Assurance Manager or equivalent)Date of signature:* The above parameters are only as an example; other test may be required forspecific product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 197
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Page 146 and 147: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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