PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Self Inspection

PIC/S Guide to Good Manufacturing Practice for Medicinal Products PICSGMP-9: Chapter 9: Self Inspection and Continuous Improvement

Per PIC/S GMP Chapter 9: self inspection. Requirements include (a) operate Self Inspection Programme including periodic internal audit of GMP compliance + (b) define scope + frequency + qualifications of inspectors + (c) document findings + classification (critical + major + minor) + responses + corrective actions + (d) maintain follow-up + verification of effectiveness + (e) implement continuous improvement including management review + trending + (f) integrate with broader quality management system + (g) maintain readiness for regulatory inspection + audit.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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