Factory Acceptance Test and Site Acceptance Test As mentioned above, the user specifications are usually general in nature. For example, they would say we need a V blender with temperature…

Determining the Level of Qualification Before determining what testing needs to be performed in the Factory Acceptance Test (FAT) or any other commissioning or qualification test, one needs to determine…

Introduction Subpart D2 of the Code of Federal Regulations is dedicated to equipment. 21 CFR 211.63 deals with design issues, 211.65 with construction, 211.67 and 68 deal with maintenance, cleaning,…

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…