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.

³Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice; FDA, Sep. 2004.

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

⁵Title 21 Code of Federal Regulations Parts 210 and 211, 2015.

⁶Process Validation A Life Cycle Approach; Grace McNally; FDA May 2011 slide presentation on www.FDA.gov

⁷Ibid.

⁸Sending team—those responsible for the current operation and instrumental in training and transferring their knowledge to the receiving team.

⁹Guidance for Industry: CMC Postapproval Manufacturing Changes to be Documented in Annual Reports; FDA—Mar. 2014.

¹⁰Ostrove, S.: Qualification and Change Control. In: Validation of Pharmaceutical Processes, 3rd Ed; Editors: Agalloco, J., Carlton, F. New York: Informa Healthcare USA, Inc., 2008, pp. 129–145.

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