¹Ostrove, S.: Qualification and Change Control. In: Validation of Pharmaceutical Processes, 3rd Ed; Editors: Agalloco, J., Carlton, F. New York: Informa Healthcare USA, Inc., 2008, Chapter 9, pp. 129–145.

²Title 21 CFR Part 211 Subpart D, FDA, 2015.

³Process Validation A Life Cycle Approach; Grace McNally; FDA May 2011 slide presentation on www.FDA.gov

⁴Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011.

⁵Stand alone system—several components working as a single unit of operation (eg, a pump and a tank).

⁶Note: This is often combined with part of the process performance qualification and may become a part of the validation teams’ efforts (whereas the IQ and OQ testing are often performed by the engineering group).

⁷Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, FDA, Sep. 2004.

⁸Bringert, G.: Calibration and Metrology, In: Validation of Pharmaceutical Processes, 3rd Ed; Editors: Agalloco, J., Carlton, F. New York: Informa Healthcare USA, Inc., 2008, Chapter 7, pp. 99–108.

Stay updated, free articles. Join our Telegram channel

Join