In June 2015 ICH issued a Q & AÂ Guidance document that complements the Guidance for Industry Active Pharmaceutical Ingredients, ICH Q7. 2000. Since 2000, experience with implementing the guidance has created a need for clarification of various sections.
ICH Q7 should be applied in combination with the principles laid down for development and manufacturing in ICH Q11 (see definition of API starting material; see also ICH Q8), Quality Risk Management (ICH Q9), and Pharmaceutical Quality Systems (ICH Q10). GMP principles as described in ICH Q7 should be applied regardless which approach is taken in pharmaceutical development and manufacturing.
Within the next few weeks I will be offering an on-line live webinar as well as a two day seminar where you can enhance your understanding of this area. The webinar, to be held on Thursday, September 17, and titled “Risk Management of Raw Materials in a GMP Environment†may be viewed at , while the seminar, Raw Material Requirements in a GMP Environment CLICK HERE, will be offered on Thursday, October 1 and Friday, October 2 in San Francisco.
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