¹Title 21 Code of Federal Regulations Parts 210 and 211, 2015.

²Guideline on General Principles of Process Val, FDA, 1987.

³Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011.

⁴Federal Resister, May 3, 1996 FDA, 21 CFR 210 and 211, Proposed Rule.

⁵Guideline on General Principles of Process Val, FDA, 1987.

⁶Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011.

⁷Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach Final Report; FDA, Sep. 2004.

⁸www.PDA.org, www.ISPE.org, www.ASQ.org

⁹Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011.

¹⁰Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011.

¹¹NOTE: for this book we will refer to the paradigm that equipment is qualified and processes are validated.

¹²Federal Food, Drug, and Cosmetic Act; Apr. 24, 2013.

¹³Guidance for Industry Process Validation: General Principles and Practices, FDA, Jan. 2011, p. 16.

¹⁴Technical Report No. 60; Process Validation: A Life Cycle Approach, Parenteral Drug Association, 2013.

¹⁵Technical Report No. 60-2; Process Validation: A Life Cycle Approach—OSD/SSD Annex, Parenteral Drug Association, In Press.

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