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GMP News No. 670
14 February 2006
New Information on ICHQ10 "Quality Systems"
We have already informed you about the new initiative of the InternationalConference on Harmonisation (ICH) for the creation of the ICH Q10guideline on "Quality Systems". Now, the ICH has published firstinformation on the objectives and the requirements on the content.
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:
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.
|Especially on the topic of "Quality Systems", the EuropeanCompliance Academy is organising:|
FDA's and ICH 's NewQuality System Approach
in Prague on 1 and 2 June