DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)GMP/ CFS TemplateAuthority name, address, countryType of certificateCompany name (product owner/ manufacturer)Product nameProduct formulation if availableDosage formStatement of freely sold (similar meaning) if for CFS certificateStandard of GMP and compliance status if for GMP certificateDuration of certificationName, signature and designation of authorized personnelDate of signatureNote: The certificate must be in English or translated into English(certified true by issuance or embassy or notary public)Attachment of Protocol AnalysisProtocol analysis is attached here.Finished Product Quality Control (FPQC)‣ The certificate must be complete with the product specification and result.The list of tests and specifications must be same with finished productspecification document.‣ Quality Control Test For Health Supplement Product are as follows:1. Limit Test for Heavy Metalsa) Lead : NMT 10.0 mg/kg or 10.0 mg/litre (10.0ppm)b) Arsenic : NMT 5.0 mg/kg or 5.0 mg/litre (5.0ppm)c) Mercury : NMT 0.5 mg/kg or 0.5 mg/litre (0.5ppm)d) Cadmium : NMT 0.3 mg/kg or 0.3 mg/litre (0.3ppm)* Required for products with ingredients from natural sources.The test shall be conducted either on the raw material or finished product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 216
Drug Registration Guidance Document (<strong>DRGD</strong>)2. Disintegration Test (for tablets, capsules and pills)Disintegration time:a) Uncoated tablets : NMT 30 minutesb) Film-coated tablets : NMT 30 minutesc) Sugar-coated tablets : NMT 60 minutesd) Enteric-coated tablets : Does not disintegrate for 120 minutes inacid solution but to disintegrate within 60minutes in buffer solutione) Capsules : NMT 30 minutesf) Pills : NMT 120 minutes3. Test for Uniformity of Weight (tablets and capsules only)i) Tablet- For tablet with average weight of 130mg or less: Not more than 2tablets differ from the average weight by more than 10% AND notablets differ from the average weight by more than 20%- For tablet with average weight between 130-324mg: Not more than 2tablets differ from the average weight by more than 7.5% AND notablet differs from the average weights by more than 15%- For tablets with average weight more than 324mg: Not more than 2tablets differ from the average weight by more than 5% AND no tabletdiffers from the average weight by more than 10%ii) CapsuleIndividual weight of the capsule to be within the limit of 90-110% of theaverage weight.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 217
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Page 166 and 167: 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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