Knowledge Management and ICH

References

1. 1.↵
   ICH Q10. Pharmaceutical quality systems. ICH, June 2008.
2. 2.↵
   ICH Q9. Quality Risk Management. ICH, November 2005.
3. 3.↵
   Q-IWG Q&A. Quality Implementation Working Group on Q8, Q9 and Q10, Questions & Answers (R4). ICH, November 2010.
4. 4.↵
   ICH Q8, Pharmaceutical Development. ICH, August 2009 [including Part I: ‘Pharmaceutical Development’, November 10 2006 and Part II: ‘Annex to Pharmaceutical Development’, ICH Q8 (R2)], November 2008, and ICH Q11, Develop and Manufacture of Drug Substance (Chemical Entities and Biotechnological/Biological Entities), May 2012.
5. 5.↵
   Training Programme for Q8/Q9/Q10. ICH Quality Implementation Working Group (Q-IWG), November 2010.
6. 6.↵
   ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation. ICH, Point to Consider (R2), December 2011.
7. 7.↵
   1. Flexman G.,
   2. Husovich M.,
   3. Orloff J.,
   4. Patel J.,
   5. Roenninger S.,
   6. Skoog M.,
   7. Torbeck L.,
   8. Weese D.

   Utilization of statistical methods for production monitoring. PDA Technical Report No 59, 2012, 1–65.