DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)SECTION C: QUALITY CONTROLThe requirement for the submission of the protocol of analysis (POA), analyticalmethod validation (AMV) and product samples for laboratory testing are presented inthis section.The submission of POA and AMV to the Centre for Quality Control shall be done viathe online system (Quest system) and also using hardcopies, once payment for theregistration has been confirmed. Documents to be submitted are listed below:Documents to be submitted via online Quest system1. E9 : Complete protocol of analysis for finished product includingpreservatives and diluents (if any).2. E10 : Summary of AMV which includes all the relevant validationcharacteristics, its acceptance criteria and results.3. E11 : Certificate of analysis for active drug substance (1 batch) andrecent batches of finished product (3 different batches).Documents to be submitted as hardcopy:1. Certificate of analysis for active drug substance (1 batch) and recent batches offinished product (3 different batches)2. Complete protocol of analysis for active drug substances and finished product(including preservatives and diluents, if any)3. Complete testing method for the AMV.4. Complete results for the AMV with all relevant validation parameters, includingacceptance criteria and supporting raw data (e.g. chromatograms, spectrums etc.)Note:1. A cover letter consisting of the following information should be enclosed with everyhard copy document submission:i) Name of product;ii) Reference Number/ Protocol Number;iii) Contact person (name/ email address/ telephone no.);iv) Name and address of company.2. Documents submitted should be well organized and indexed.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 86
Drug Registration Guidance Document (<strong>DRGD</strong>)9. GUIDELINE FOR THE SUBMISSION OF PROTOCOL OFANALYSIS (POA)This guideline consists of general and specific requirements for the POA submission.The general requirements are referred to POA content whilst details of the testmethods are illustrated in the specific requirements9.1 GENERAL REQUIREMENTSa) The POA shall be written in Bahasa Malaysia or English only.b) The POA shall contain the following information:i) Name of product;ii) Name and address of manufacturer;iii) Name, signature and designation of authorized person;iv) Effective date and Review date.c) The POA shall comply with the following requirements :i) To provide updated testing methods, shelf-life specifications and certificate ofanalysis for the intended product to be registered.ii) References used must be clearly stated.iii) The latest version of British Pharmacopoeia (BP) and United StatePharmacopeia (USP) shall be used as the main references.iv) All tests and its specification listed in BP and/or USP shall be the minimumrequirement. However, a specific testing method for quantitative analysis shallbe accepted.v) All test specifications set by the manufacturer shall be in line or more stringentthan official pharmacopoeias (BP and USP).d) Details of test methods shall include the following items:i) List of equipment and apparatus;ii) List of chemical, reagents and media;iii) Preparation of solutions such as sample, standard, mobile phase, medium etc.;iv) Setting up of analytical instrumentation;v) System suitability tests (resolution, percentage of Relative Standard Deviation(%RSD), tailing factor and theoretical plate for High Performance LiquidChromatography (HPLC) and Gas Chromatography (GC) methods);vi) Complete formula for calculation and interpretation of results;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 87
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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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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