Most facility development programs begin with a programming exercise. Multi-product, multi-market plans often carry with them the compliance differences that correspond to the proposed market.
For example, designing a receiving area for satisfying the PIC/S or Japanese Ministry of Health requirements of labeling control is potentially very different from trying to satisfy the security and control requirements of the USFDA. Similarly, as the product mix increases in complexity, so potentially does the space and facility classification requirements.
Having a clear understanding of these differences will maximize the usefulness of the facility and reduce the risk of non-compliance during a pre-approval inspection.
This cleanroom tip was taken from “Facility Harmonization Challenges for the Global Marketplace,” which appeared in the March 2013 issue of Controlled Environments.
