Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation - Pharmaceutical Technology

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Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation
A risk-management assessment of visible-residue limits (VRL) in cleaning validation of pharmaceutical formulations was conducted for both pharmaceutical pilot plant and manufacturing facilities. The authors discuss how potential risks were identified, analyzed for probability, considered for seriousness, and controlled through avoidance or mitigation. These opportunities for VRL implementation then were identified for both pilot plant and manufacturing settings.


Pharmaceutical Technology


10. R.J. Forsyth et al. "Correlation of Visible Residue Limits with Swab Results for Cleaning Validation," Pharm. Technol., in-press.

11. European Commission, "Qualification and Validation," EudraLex, Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice, Vol. 4, Annex 15 (European Commission, Brussels, Belgium, July 2001).

12. Pharmaceutical Inspection Cooperation Scheme (PIC/S), Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation, (PIC/S, Geneva, Switzerland, August 2002).

13. Health Canada, Health Products and Food Branch Inspectorate, "Cleaning Validation Guidelines" (Health Canada, Ottawa, Ontario, Canada, June 2002).

14. R. Sharnez, et al., "In Situ Monitoring of Soil Dissolution Dynamics: A Rapid and Simple Method for Determining Worst-Case Soils for Cleaning Validation," PDA J. Pharm. Sci. and Technol. 58 (4), 203-214 (2004).

Richard Forsyth* is an associate director in global clinical GMP quality with Merck & Co., Inc, WP53C-307, West Point, PA 19486, tel. 215.652.7462, fax 215.652.7106,
Jeffrey Hartman** is a validation manager in regulatory and analytical sciences with Merck & Co., Inc., WP97B-120, West Point, PA 19486, tel. 215.652.8101, fax 215.652.3314,
and Vince Van Nostrand is a research chemist in medicinal chemistry with Merck and Co., Inc.

*To whom pilot-plant correspondence should be addressed.

** To whom manufacturing correspondence should be addressed.

Submitted: May 16, 2006. Accepted: June 21, 2006.

Keywords: cleaning, inspection, risk management, validation, visible residue limit, VRL


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