New Information on ICH Q10 "Quality Systems"

New Information on ICH Q10 "Quality Systems"

The ICH suggests that a three-part guideline be created for the description of modern quality assurance systems. These systems are meant to contribute to assuring the high quality of medicinal products by means of continuous testing and to facilitate their further improvement over their life cycle.

According to ICH, the new guideline should extend existing GMP requirements by adding modern quality assurance systems for production and thus stabilise processes. The aim of this is to help active pharmaceutical ingredients and medicinal products to comply with the requirements on drug quality.

In developing the guideline, the ICH intends to revert to existing documents:

• ISO 9000: "Quality Management Systems"-- fundamentals and vocabulary;
• ISO 9001: 2000: "Quality Management Systems"-- requirements;
• ISO 9004: "Quality Management Systems" -- guidelines for performance improvement;
• Eudralex Volume 4: "Medicinal Product for Human and Veterinary Use: Good Manufacturing Practice";
• ICH Q7: "Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients";
• US FDA: "Draft Guidance for Industry Concerning Quality Systems Approach to Pharmaceutical current Good Manufacturing Practice Regulations";
• ISO 13485: 2003 Medical devices -- Quality management systems; Requirements for regulatory purposes.

The ICH plans to bring these elements together in a new guideline for quality assurance systems and thus to create a globally harmonised system. Besides, the guideline concentrates on systems facilitating the implementation of ICH Q8 "Pharmaceutical Development" as well as ICH Q9 "Quality Risk Management" and thus making use of the advantages of both guidelines.

The proposed guideline, which is meant to be published in spring 2007 for commenting by the industry, would encompass the whole life cycle of active pharmaceutical ingredients and medicinal products and include the development of processes, technology transfer as well as routine production.
  

 
Author:
Wolfgang Heimes
on behalf of ECA

Source: ICH web page: http://www.ich.org/cache/html/1574-272-1.html