Draft ICH Q10 Guideline Published for Public Comment

The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System.

The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System. The draft guidance was prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a project of the regulatory authorities of Europe, Japan, and the United States that seeks to coordinate guidelines and requirements in the three regions.

According to the document, the guidance provides “one comprehensive approach” to an effective pharmaceutical quality system that is based on International Organization for Standardization concepts, includes applicable GMP regulations, and complements the ICH guidances Q8, Pharmaceutical Development and Q9, Quality Risk Management, which were both implemented in the three regions last year.

The guidance applies to drug substances and drug products, including biotechnology and biological products, and offers advice on how to apply quality systems throughout various steps in the product lifecycle, including pharmaceutical development, technology transfer, manufacturing, and product discontinuation. The objectives of the Q10 guidance are to “achieve product realization, [i.e., to ensure product quality], establish and maintain a state of control, and facilitate continual improvement.”

The draft ICH Q10 document has been issued almost an year after the FDA published its own guidance-Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations-in September 2006. “The FDA guideline is primarily based on US cGMPs while the ICH is written to be overarching over all GMPs internationally,” said an FDA spokesperson. “When Q10 is finalized we will consider what amendments will be needed for FDA’s guidance.”

The draft guidance was released as Step 3 of the ICH process, in which the guidance is published in the three ICH regions for public comment. Comments are due to the FDA by October 11, 2007, and to EMEA in November.