Audit Risk from Unrevised Autoclave SOPs After Cycle Revalidation
Audit Risk from Unrevised Autoclave SOPs After Cycle Revalidation Aligning Autoclave SOPs with Revalidated Sterilization Cycles for GMP Compliance Introduction to the Audit Finding 1. What Is the Issue? Autoclaves are revalidated to confirm sterilization effectiveness over time. However, many facilities fail to update associated SOPs to reflect revised cycle parameters, loading configurations, or hold…
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