DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)16.2.2 CONDITIONS ON GOOD MANUFACTURING PRACTICE (GMP):a) The new manufacturing site shall comply with current Good ManufacturingPractice (cGMP);b) Local manufacturing sites are subjected to pre-licensing inspections by theNPCB inspectors;c) For manufacturing sites outside Malaysia, certification on GMP by the competentauthority is acceptable.d) The Authority reserves the right to conduct an inspection on any manufacturingsite.e) For further information pertaining to the requirements on GMP, please refer tothese circulars and directive.i) Bil (35) dlm. BPFK/PPP/01/03ii) Bil (40) dlm. BPFK/PPP/01/03iii) Bil (25) dlm BPFK/PPP/01/03 Jld 1iv) Bil (96)dlm.BPFK/PPP/01/03 Jld. 216.2.3 TYPES OF MANUFACTURING SITE CHANGES (COS)Table XVI:No. Types of COS Description1. Type I2. Type IIChange ofmanufacturingsite withinMalaysiaChange ofmanufacturingsite fromforeign countryto MalaysiaChange in the location of the site of manufacturewithin Malaysia only. This change may be due toupgrading of facilities, and/or expansion ofmanufacturing activities or moving to a newlyconstructed plant.Change in location of the site of manufacture fromoutside of Malaysia to a location in Malaysia. Thischange may be due to the ability of the localcounterpart to manufacture the product.3. Type IIIChange ofmanufacturingsite locatedoutsideMalaysiaChange of location of the site of manufacture tomanufacturing facilities located outside Malaysia. Thismay be due to a merger or rationalization ofmanufacturing sites in line with multinationals‟manufacturing strategies.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 111