Biomedical Engineering Reference
In-Depth Information
8. Product specification file is defined in Annex 13 of the EU GMPs: Manufacture
of Investigational Medicinal Products. The concept of design controls and a design
history file is described in the Quality System Regulation for Medical Devices, 21CFR
part 820.
9. FDA Guidance for Industry Process Validation: General Principles and Practices,
January 2011.
10. Guideline on strategies to identify and mitigate risks for first-in-human clinical trials
with investigational medicinal products, EMEA, July 2007.
11. FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs, July 2008.
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