box 2, B - 1160 Brussels, Tel: +32 (0)2 676 72 11, www.cefic.org. Document Type:.
Work Products. ICH Guidelines; Process of Harmonisation · MedDRA · CTD · Electronic Standards · Consideration Documents · Public Consultations · GCP Renovation
These guidelines are intended to assist applicants in the compilation of the information on APIs in their dossiers for prequalification or when submitting a variation to a dossier
APIC's membership consists of companies from different pharmaceutical industry sectors, all involved in the manufacture of APIs. This provides an ideal basis for developing and communicating a balanced, holistic view on API-related regulations and guidelines. APIC's focus is on worldwide Quality, Good Manufacturing
Q7 Good Manufacturing. Practice Guidance for Active. Pharmaceutical Ingredients. Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). September 2016. ICH.
16 Sep 2015 Shortly after the entry into force of the Good Manufacturing Guide for Active Pharmaceutical Ingredients ICH Q7 in the year 2000 the Active Pharmaceutical Ingredients Committee APIC wrote the "How to do" document which clarifies the requirements of the guideline on the basis of experience gained from
This document (guide) is intended to provide guidance regarding good manufacturing practices (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No.
The Committee was informed of the background to the development of the ICH GMP guidelines for active pharmaceutical ingredients (APIs), including the earlier involvement of the Pharmaceutical Inspection Cooperation Scheme in initiating the preparation of this guide. The Committee recognized the difficulty that countries

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February 2018