Search results with tag "Cleaning validation in active pharmaceutical ingredient"
Guidance on aspects of cleaning validation in active ...
apic.cefic.orgCleaning Validation Guidance 3 1.0 Foreword This document has been prepared by the cleaning validation task force within the active pharmaceutical ingredient committee (APIC) of CEFIC. In recent years the subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has received a large amount of attention from regulators,
GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN …
apic.cefic.orgThe subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike. The integration of Cleaning Validation within an effective Quality System supported by
CLEANING VALIDATION WITH RISK ASSESSMENT
www.usp-pqm.orgUS FDA Draft Guidance for Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (1998) APIC Guide “Cleaning Validation in Active Pharmaceutical Ingredient Manufacturing Plants (1999)” & Companion Document “Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants (2000)”