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Search results with tag "Finished pharmaceutical"
Stability Studies - WHO
www.who.int(API) or Finished Pharmaceutical Product (FPP) varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. The ... multisource (generic) finished pharmaceutical product (FPP) has been revised: Preparation of Product Dossiers (PDS) in Common Technical Document (CTD) format
Annex 10 - ICH
database.ich.orgfor a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part4) and WHO guidelines (on the active pharmaceutical ingredient master file procedure (5). It is recommended that these …
GUIDELINE ON SUBMISSION OF …
www.pharmalytik.comworking document qas/10.373/rev.1 restricted 1 2 3 4 5 guideline on submission of documentation for a 6 multisource (generic) finished pharmaceutical 7 …