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The following are provided in electronic format in the Chapter 1 Appendix (www.wiley.com/go/Bliesner/LabControl_GMPEnvironment):

 21 Code of Federal Regulations Parts 210 and 211 – Current Good Manufacturing Practice Regulations, Revised as of April 1, 2005

 US FDA Compliance Programs to FDA staff, Chapter 56: Drug Quality Assurance 7366.002 Drug Manufacturing Inspections, October 31, 2017.

 US FDA Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006.