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, richard_forsyth@merck.com
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, jeffrey_hartman@merck.com
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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