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REGULATION

Comment Periods Open for ICH Q10 and Biologics Guidelines

The US Food and Drug Administration announced in mid-July the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal Register (Docket 2007D-0266, CDER 200783).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, which is open for public comment until Oct. 11, 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 Management.'" The guideline, which is optional, applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.


Company Notes
FDA also opened for public comment until Sept. 21, its draft guidance for industry, Cooperative Manufacturing Arrangements for Licensed Biologics. The announcement, released in the Federal Register (Docket 1999D-2013), relates to "cooperative manufacturing arrangements applicable to biological products licensure under section 351 of the US Public Health Service Act," including short-supply, divided manufacturing, shared manufacturing, and contract manufacturing arrangements.

Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements for the licensed manufacturer, contract manufacturer, and final-product manufacturer.
-Maribel Rios


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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