^*Bold text in this chapter is by the author for clarity only.

¹ASTM E 2500-07; Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment; Jun. 2007.

²Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011.

³Guidance for Industry: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; FDA, Aug. 2001.

⁴Guide to the Inspections Validation of Cleaning Processes; FDA Jul. 1993.

⁵ICH is formed by the United States, European Union, and Japan and is binding on each of these “countries” so as to facilitate inspections respectively.

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