ICH Q10 Ready for Comment - July 19, 2007

The FDA recently announced the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal Register. The public comment period is open until October 11, 2007.

The ICH Q10 draft guideline describes one approach for “an effective pharmaceutical quality system that is based on ISO concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 ‘Pharmaceutical Development’ and Q9 ‘Quality Risk Mangement.’” The guideline, which is optional, applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

Read the Q10 Guidance document. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

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