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Since the ICH guidance Q11 Development and Manufacture of Drug Substances (ICH Q11) was finalized, worldwide experience with implementation of the recommendations on the development and ...
Interpretation of the high level principles in ICH Q11 for the selection and justification of starting materials is not fully aligned between and within regulatory bodies and industry. Further discussion on the specific areas of divergent interpretation and subsequent clarification will benefit harmonisation in this area.
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This guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD).
6. Q11 Q&A Selection & Justification of Starting Materials. Section 5.1.1 Selection of Starting Materials for Synthetic Drug Substances. 6 general principles for consideration. 1. In general, changes....that occur near the beginning o f the process have lower potential to impact the quality of the drug substance. 2.
Consistent with modern global manufacturing and scientific practices (described in the ICH Quality Vision presented and endorsed in Brussels, July 2003), and economic considerations, the development and establishment of a robust manufacturing process for drug substances to deliver a product of consistent quality accounts for a significant proportion of manufacturers’ resources and efforts ...
Preface Since the ICH Q11 guideline was finalised, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials.
