DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)No. Types of COS Descriptioni) Transfer of manufacturing of an asepticallyprocessed sterile product to a:a) newly constructed or refurbished asepticprocessing facility or area;4. Type IV5. Type VChange ofmanufacturingsite for sterileproductsChange ofmanufacturingsite in crisissituationb) an existing processing facility or area that doesnot manufacture similar approved products.(For example, transferring the manufacture of alyophilized product to an existing asepticprocess area where there is no approvedlyophilized product is manufactured).ii) Transfer of a finished product sterilized by terminalprocesses to a newly constructed facility at adifferent manufacturing site.Once this change has been approved, subsequentsite changes to the facility for similar types ofproduct and processes will not be categorized as aType IV COS.i) Change of location of the site of manufacture thatis deemed necessary due to certain circumstancessuch as natural disasters, closure or suspension ofpremise (revocation of manufacturing license) andmatters related to breach of product quality, safetyand efficacy ONLY.ii) Prior to submission of Type V COS, approval letterissued by the secretariat of the Authority shall beobtained.iii) Application for Type V COS must be made withinthree (3) months from the date of the crisis.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 112