DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 6:GUIDELINE ON REGULATORY CONTROL OF ACTIVEPHARMACEUTICAL INGREDIENTS (API)(Version 2.1)Outline:1. Introduction2. Definition2.1 Definition of Active Pharmaceutical Ingredient (API)2.2 Classification of Active Pharmaceutical Ingredient (API)3. Scope4. Procedure for Submission4.1 How to Submit4.2 Required Information4.3 Other Considerations4.4 Processing Fee5. Drug Master File (DMF)6. Certificates of Suitability (CEP)7. Full Details of API Information in the Product Dossier Application8. Stability Data of API9. Site Inspection10. Maintenance of Approval StatusNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 312
Drug Registration Guidance Document (<strong>DRGD</strong>)1. INTRODUCTION1.1. A significant part of the quality of a finished pharmaceutical product isdependent on the quality of the Active Pharmaceutical ingredients (APIs)used for its formulation. Thus, a proper system of qualification of suppliers isnecessary to ensure a constant sourcing of APIs of appropriate quality andto safeguard the public health interests. This will be done throughstandardized quality assessment and inspection procedures.1.2. The National Pharmaceutical Control Bureau (NPCB) under the purview ofthe Ministry of Health Malaysia will introduce mandatory control of APIs aspart of the requirements in the product registration application. This will beimplemented prospectively according to a phased timeline established bythe NPCB.1.3. The implementation will begin with voluntary submission for New ChemicalEntities in April 2011 and followed by;Phase 1 - New Chemical Entity (mandatory in Jan 2012)Phase 2 - Scheduled Poison, (to be determined)Phase 3 - Non-scheduled Poison (to be determined)1.4. The procedure for control of APIs established by the NPCB is based on thefollowing principles:A general understanding of the production and quality control activities ofthe manufacturer;Assessment of API data and information, including changes andvariations, submitted by the product registration holder (PRH)/ APImanufacturer. These data should include the manufacturing process,material specifications and test data and results;Assessment of the manufacturing site(s) for consistency in productionand quality control of raw materials, with specific emphasis on key rawmaterials and APIs during and after purification through compliance withGood Manufacturing Practice (GMP);Random sampling and testing of APIs (post-marketing surveillance);Handling of complaints and recalls; andMonitoring of complaints from other agencies and countries.1.5. This guideline is intended to provide guidance regarding the requirements tobe included for APIs in the quality part of the product dossier.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 313
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PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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