Appendix A: Pharmaceutical Quality System Models
In 2009 the International Conference on Harmonization (ICH) published a guidance with recommendations for a Pharmaceutical Quality System (PQS).1 The U.S. Food and Drug Administration (FDA) had earlier published a similar set of guidelines with more detail related to U.S drug regulations.2 These guidance documents are quite helpful. Although drug regulations do not require establishment of a QMS, responsible pharmaceutical manufacturers have implemented systems tailored to their needs.
ICH MODEL
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10 guidance is probably the more influential. Figure A.1 indicates the concepts of the ICH ...
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