Developing a Sound Process Validation Strategy - - BioPharm International

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Developing a Sound Process Validation Strategy


BioPharm International
Volume 20, Issue 12

5. Shadle PJ. Qualification of raw materials for biopharmaceutical use. BioPharm Int. 2004; 2:28–41.

6. Ritter N, et al. What is test method qualification? Proceedings of the WCBP Strategy Forum. 2003 Jul 24. Gaithersburg, MD.

7. ICH. Q2(R1), Validation of analytical procedures: text and methodology. Geneva, Switzerland; 2005.

8. Brunkow R, et al. Cleaning and cleaning validation: a biotechnology perspective. Bethesda, MD: Parenteral Drug Association; 1995.

9. Hall W. Validation and verification of cleaning processes. In: Nash R, Wachter A. editors. Pharmaceutical process validation. New York: Informa Health Care; 2003. p. 465–506.

10. The Automotive Division of the American Society for Quality (ASQC) and the Automotive Industry Action Group (AIAG). Potential failure mode and effects analysis, FMEA. 1995 Feb. Southfield, MI: AIAG.

11. Montgomery DC. Design and Analysis of Experiments, 4th ed. New York: John Wiley & Sons, Inc.; 1997.

12. Parenteral Drug Association. PDA technical report no. 42: Process validation of protein manufacturing. Bethesda, MD: PDA; 2005.

13. US Food and Drug Administration. Guidance for industry. Guidelines on general principles of process validation. Rockville, MD; 1987.

14. Ferenc BM. Qualification and change control in validation of pharmaceutical processes, 2nd ed.; Carleton F, Agalloco J. editors. New York: Marcell Dekker, Inc.; 1999; p. 132–150.

15. The Automotive Division of the American Society for Quality (ASQC) and the Automotive Industry Action Group (AIAG). Statistical process control (SPC) reference manual; 1995 Mar. Southfield, MI: AIAG.


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