Challenge: A leading global pharmaceutical company contracted Beaufort to assess and re-validate their manufacturing equipment cleaning process.

Beaufort Solution: Beaufort’s QA team conducted an analysis of all the possible chemical interactions of all the components of the client nine different formulations and developed a cross-contamination matrix. Concurrently, all possible equipment configurations were classified by total product contact surface area. Working directly with our client’s corporate R&D and QA teams and their manufacturing site team, we facilitated cross-functional failure mode and effect analysis (FMEA) workshops and analysis efforts to identify worst cases based on risk.  We also developed the new Cleaning Validation Strategy, created all the engineering studies and validation protocols, and identified improvements using statistically sound sampling plans, visual and readily available work instructions, and hands-on training of all personnel involved with the cleaning process. As a result, our client has a fully developed strategy and executable master plan to validate an efficient, better performing cleaning process with all the documented evidence to prove it.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance