In this case study, risk as reduced by applying a structured and standardized approach to determine minimum facility cleaning
requirements. The frequency was predicated on good scientific principles and an understanding of the facility design, process
characteristics (e.g., historical dust generating capabilities), and product susceptibility (e.g., inherent microbial inhibition,
water content). Risk was further mitigated by routine facility audits to ensure that cleaning choices and frequencies are
sufficient for maintaining facilities in a GMP-compliant state.
Risk communication and documentation
The risk analysis was reviewed by a senior level quality standards committee to gain alignment on operating principles, risk
analysis, and risk controls. The resulting tools of the analysis (i.e., the prioritization table and decision tree) are now
codified in a company quality guidance document. The quality guidance is used to establish local standard operating procedures
for execution at the shop-floor level. Training is performed against the operating procedure and training records are periodically
audited for compliance.
As part of the firm's standard practice for the ongoing maintenance of quality guidances, the subject risk analysis (defined
as part of the company guideline on facility cleaning) is reviewed by subject matter experts on a periodic basis to ensure
that the assumptions and decisions remain valid and justified.
Ted Frank is with Merck & Co; Stephen Brooks, Kristin Murray,* and Steve Reich are with Pfizer; Ed Sanchez is with Johnson & Johnson; Brian Hasselbalch is with the FDA Center for Drug Evaluation and Research; Kwame Obeng is with Bristol Myers Squibb; and Richard Creekmore is with AstraZeneca.
*To whom all correspondence should be addressed, at firstname.lastname@example.org
1. T. Frank et al., Pharm. Technol.
35 (7), pp. 72–79.