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1Pharmaceutical CGMPs for the 21st Century–A Risk-Based Approach Final Report; FDA, Sep. 2004. 2Guidance for Industry; Q 10 Pharmaceutical Quality Systems Q10, FDA, Apr. 2009 ICH. 3Guide to the Inspection…

Basic Risk Approach4 A risk-based program needs to be established at the very beginning of the process validation program. Some criteria to be included in this risk program are: • Documentation…

Quality Programs The Quality Program approach should be used for all CGMP activities. The FDA and the ICH have guidelines1,2 regarding this approach (see Appendix C). The Quality Programs are…

Standard Operating Procedures (SOPs) Preparation In the preparation of SOPs there are often higher levels of documents that control the functionality of the various systems and operations. At a corporate…

Getting Started (After the Equipment Specifications) Process validation cannot begin when the first commercial size batch is produced. It must start much earlier. In reality, process validation begins in the…

1Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011. 2Pluta, P.: FDA Life Cycle Approach to Process Validation—What, Why, and How. J. Validation Technology Spring, 51–61; 2011….