Ever since the concept of process validation was first introduced in the 1970s, it has undergone continual improvement but in the last few years, it has undergone a paradigm shift. Instead of validating a certain set of process parameters without the full understanding of whether it was close to an edge of failure, the Quality by Design (QbD) initiative, principle component analysis (PCA), and neural nets have converged to revolutionize the assessment of what is a critical process parameter and how best to control its impact on product quality or structure activity relationships.
This evolutionary thought process is evident in the Center for Device & Radiological Health (CDRH) requirements for HACCP (Hazard Analysis & Critical Control Point) for medical devices, the Center for Biologics Evaluation & Review (CBER) guidance on biologics process development & validation, as well as the Center for Drug Evaluation & Review (CDER) guidance on cGMPs in the 21st Century.
Compliance Strategies, Inc. has extensive experience in the review and evaluation of process controls and specifications germane to product quality.
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