FDA Opens Comment Period on ICH Q10 Draft Guideline

Rockville, MD (July 13)-The US Food and Drug Administration announced the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal Register (Docket 2007D-0266, CDER 200783).

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.

The document specifically outlines the “product lifecycle” to include pharmaceutical development, technology transfer, manufacturing, and product discontinuation. Among the areas discussed in the guideline are management responsibility (including planning, management, communication, and review), continual improvement of process performance and product quality (including lifecycle stage goals), and continual improvement of the pharmaceutical quality system (including monitoring internal and external impact factors).

The draft guideline (

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) is open for public comment until Oct. 11, 2007.