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ICH Q11, the pending guideline from the International Conference on Harmonization titled Development and Manufacture of Drug Substances, may be one of the most anticipated guidelines in the global pharmaceutical industry in recent years (1). Since 2004, the industry has been working to reshape its approach to drug manufacturing based on FDA's Pharmaceutical CGMPs for the 21st Century initiative, which were cemented between 2005 and 2008 by the so-called ICH Quality trio guidelines (2). These globally harmonized guidelines, which include ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, detailed quality-by-design (QbD) concepts for pharmaceutical manufacturing and redefined the industry lexicon with terms such as quality target product profile, critical quality attributes and critical process parameters (CQAs and CPPs), knowledge management, product life-cycle management, and control strategy (3–5). The Q11 guideline, which was published as a draft in May 2011 and is expected to be adopted by the ICH steering committee this year, both complements and enhances these concepts by offering industry guidance and clarity "regarding the description and justification of development and manufacturing processes for drug substances and the type and extent of information to be submitted in regulatory dossiers" (6). |
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- 附件 1 : q11.doc
2012-02-15 20:10:37, 57.5 K
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