DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED13. Change in storageconditionsA15P8D1D2D3A12B5D1D2D3CONDITIONThe studies must show conformance to the currentshelf life specification.SUPPORTING DOCUMENTS1. Results of appropriate real time stability studiescovering the duration of currently approved endof-shelflife (at proposed storage condition) of atleast 2 pilot/ production scale batches of theproduct and in the authorized packaging materialin accordance with the ASEAN Guidelines onStability Study of Drug Product.2. Revised drafts of the package insert and labelingincorporating the proposed variation (ifapplicable).14. Appointment, deletion orchange of othermanufacturersD1D2D3E14E12E3F12D1D2D3SUPPORTING DOCUMENTS1. GMP certificates of the proposed othermanufacturers.2. Description of the manufacturing activity of allother manufacturers involved (includingassembling process).3. Letter of appointment and acceptance for contractof other manufacturers.4. Revised drafts of the labeling incorporating theproposed variation (where applicable).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 474