Guideline on submission of manufacturing process validation
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Guideline on process validation for the manufacture of ...
www.ema.europa.euGuideline on process validation for the manufacture of biotechnology-derived active substances and data to be prov ided in the regulatory submission
Guideline on process validation for finished products ...
www.ema.europa.euThis document is intended to provide guidance on the process validation information and da ta to be provided in regulatory submission s for the finished dosage forms ...
GUIDANCE ON GOOD MANUFACTURING PRACTICES
www.who.intworking document qas/15.625 page 2 37 schedule for the proposed adoption process of document 38 qas/15.625: 39 guidance on good manufacturing practices: inspection report
Draft Annex 15 - V12 200115 - for PICS and EC adoption
academy.gmp-compliance.org2 Principle This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal
ICH Topic Q 1 A Stability Testing Guidelines: Stability ...
www.pharma.gally.chCPMP/ICH/380/95 2/13 DRUG SUBSTANCE General Information on the stability of the drug substance is an integral part of the systematic
Annex 2 - World Health Organization
www.who.intAnnex 2 65 The level of effort, formality and documentation of the QRM process should be commensurate with the level of risk. In addition to the two principles above, the following principles are also part of the QRM methodology: