ICH Q11 Reaches Harmonization, Implementation is Next

PharmTech Talk » ICH Q11 Reaches Harmonization, Implementation is Next:

"ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. Q11 was published as a draft in May 2011 and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organizations in the US, Europe, and Japan), have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies, including FDA, will publish the guideline as official guidance within their appropriate regions and implementation will begin."

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FDA Final Guidance On ICH Q10 - Quality Control System

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If you follow quality issues in the GMP regulated industry space, you'll want to get up to speed on ICH Q10. Here's what the FDA has to say about this new guidance, FDA - Q10 Pharmaceutical Quality System:

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

In summary, the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system by building upon good manufacturing practices (GMP). 

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