There is really nothing new or anything different if you go through the ICH Q10 carefully!! Yes, it was already there. Reached to level 2 and released on May 2007, the new Guideline ICH Q10 "Pharmaceutical Quality System" defines that a documented Quality System should be established. Such a quality system should consider not only the GMP requirements but also further standards such as the ISO Standard 9001.
The Quality System shall ensure conformity of each manufactured medicinal product with the quality as specified in the product's marketing authorisation / registration.
Elements like Corrective and Preventive Action (CAPA) and Continual Improvement are covered as well as Management responsibilities and Design Control.
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