Best Practices for CAPA Documentation in GMP Stability Protocols
Corrective and Preventive Actions (CAPA) are fundamental to Good Manufacturing Practices (GMP) and pharmaceutical quality systems. In the context of stability testing, any deviation—whether due to temperature excursions, out-of-specification (OOS) results, or documentation gaps—must be addressed through a compliant and traceable CAPA system. This article outlines best practices for documenting CAPA in stability protocols to…
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