Facility Design Review

A comprehensive review of facility designs before committing budget and resources is critical. This aspect of the drug development process cannot easily be undone.

GMP Compliant Facility Design

Designing facilities compliant with current Good Manufacturing Practices is critical in the first step in ensuring that your products or your client's products get approved. Jeff Yuen and Associates has experience working with and within the FDA to ensure that critical personnel and product flow considerations are incorporated into early plans.

We can help ensure that your facility design is suitable to support your product types and stage of development ranging from early stage clinical trials through facilities for commercial production.

The cost of having to renovate or upgrade a GMP facility because of inadequate personnel, material, product, waste flows can be difficult to explain to senior management or Board members after the fact. From a cGMP and PAI inspection perspective, a well-designed facility provides the "first impression" that communicates confidence and commitment to quality and compliance. Typically, facility tours are a routine part of any regulatory inspection. Properly designed, sized facilities speak inherently to a company's commitment to adequate personnel, material, product, and waste flows. The elimination of unnecessary or excessive cross-traffic or cross-flows between clean and dirty equipment or product and waste are key design features that must be considered with any facility design.

In addition, JYA is expert in sterile drug and biotech facility design. Jeff Yuen, former LOS-DO Drug Team Leader and PAI Manager was instrumental in conducting pharmaceutical and biotech facility reviews with industry during his tenure with FDA in the Los Angeles District Office. Depending on the type and nature of API or finished drug product (dosage form), there are special air handling unit (AHU) and pressure differential requirements. Products derived from mammalian cell lines (pre-viral vs. post-viral production areas), and beta lactams, cephalosporins, prions, steroidal/hormonal, and cytotoxic or high potency products require special facility designs to be in compliance with cGMPs.