¹Note: Stage III is Continued Process Verification—this allows one to add or delete CPPs and/or CQAs based on production. This will be discussed in Chapter 10, “Stage III—Collection and Evaluating Production Data.”

²Chapman, K.: The PAR Approach to Process Validation. Pharmaceutical Technology 8(12), 22–36, 1984.

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

⁴Note: It is sometimes possible to execute the validation runs during the scale up phase of the program. However, it is recommended that the scale used be approximately 75% of production. Full production scale is preferred.

⁵Ostrove, S.: Scale-up and Process Validation. In: Levine, M., editor, Pharmaceutical Process Scale-up. New York: Informa Healthcare USA, 2011, Chapter 4, pp. 109–116.

⁶ISO Standard 2859.

⁷WHO Guidelines for Sampling of Pharmaceutical Products and Related Materials, WHO Technical Report Series No. 929, 2005.

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