New Information on ICH Q10 "Quality Systems"

New Information on ICHQ10 "Quality Systems"

The ICHsuggests that a three-part guideline be created for the descriptionof modern quality assurance systems. These systems are meant to contributeto assuring the high quality of medicinal products by means of continuoustesting and to facilitate their further improvement over their life cycle.

Accordingto ICH, the new guideline should extend existing GMP requirements byadding modern quality assurance systems for production and thus stabiliseprocesses. The aim of this is to help active pharmaceutical ingredientsand medicinal products to comply with the requirements on drug quality.

Indeveloping the guideline, the ICH intends to revert to existing documents:

• ISO 9000: "Quality Management Systems"-- fundamentals andvocabulary;
• ISO 9001: 2000: "Quality Management Systems"--requirements;
• ISO 9004: "Quality Management Systems" -- guidelines forperformance improvement;
• Eudralex Volume 4: "Medicinal Product for Human and VeterinaryUse: Good Manufacturing Practice";
• ICH Q7: "Good Manufacturing Practice Guidance for ActivePharmaceutical Ingredients";
• US FDA: "Draft Guidance for Industry Concerning Quality SystemsApproach to Pharmaceutical current Good Manufacturing PracticeRegulations";
• ISO 13485: 2003 Medical devices -- Quality management systems;Requirements for regulatory purposes.

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

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

 
Author:
Wolfgang Heimes
on behalf of ECA