The Changing Role of Quality Assurance in the Pharmaceutical Industry

References

1. 1.↵
   ICH Q10 Pharmaceutical Quality System, www.ich.org.
2. 2.↵
   ICH Q8 Pharmaceutical Development, www.ich.org.
3. 3.↵
   ICH Q9 Quality Risk Management, www.ich.org.
4. 4.↵
   ICH Q11, Development and Manufacture of Drug Substances, www.ich.org.
5. 5.↵
   FDA Guidance for Industry, Process Validation: General Principles and Practices, January 2011.
6. 6.↵
   1. Kieffer R. G.,
   2. Stoker J. R.,
   3. Nally J.

   The knowledge and skills of the successful QA/QC manager. Pharm. Technol. 1998, 21 (1), 70–78.

   OpenUrl
7. 7.↵
   1. Deming W. E.

   The New Economics for Industry, Government, Education, 2nd ed.; MIT Press: Cambridge, MA, 2000.