A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.
KADMY - STOCK.ADOBE.COM
Submitted: December 1, 2020
Accepted: February 5, 2021
Cleaning validation requires a significant effort to design a strategic and effective program that is defendable with regulatory agencies. Of primary concern is what to validate. A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.
Click here to read Grouping Products and Equipment for a Worst-Case Cleaning Validation Study (PDF).Richard Forsyth is a Principal Consultant with Forsyth Pharmaceutical Consulting.
Pharmaceutical Technology
Vol. 45, No. 8
August 2021
Pages: 44–51
When referring to this article, please cite it as R. Forsyth, "Grouping Products and Equipment for a Worst-Case Cleaning Validation Study," Pharmaceutical Technology 45 (8) 2021.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.