Risk And Quality Management - A Supplier's Perspective
By Leonard J Goren and Kenneth P Clapp
Included in the report is draft guidance on the role of quality systems in the pharmaceutical cGMPs that enable manufacturers to tailor their quality system to fit their specific manufacturing environment. Per the final report, the "intensity of FDA oversight needed will be related to several factors, including the degree of a manufacturer's product and process understanding and the robustness of the quality system controlling their process." Per the QSIT handbook, site inspections will utilize FDA's system-based drug inspection, which includes inspection of two or more systems, one being the quality system. One of the six additional systems subject to inspection is the facility and equipment system.
The focus herein is specific to the application of risk management and quality systems management to facility and equipment systems. From a packaged equipment supplier's point of view, the impact of a risk-based, quality management system ranges from minimal to severe. It's been a wild ride, and our goal is to share some of what we've learned thus far.
Supplier qualification is mandated in the Code of Federal Regulations (#21), but (until recently) has often been followed only at a superficial level (i.e. a top line supplier audit). FDA 483s have focused the ‘assumptions' of quality versus proof of quality. In practice (for example), the drug manufacturing specifications are often audited at the system (skid or module) supplier level, but the specifications and quality expectations, and proof of conformance, are rarely passed down to sub-suppliers. As a result, FDA 483s can render the equipment unusable for its intended purpose.