Validaion02 过程能力确认.pptVIP

Validation Part 2: Cleaning validation Validation Objectives To review: General requirements Validation protocol requirements How to check limits Analytical requirements Sample methods Validation Why cleaning validation is so important (1) Pharmaceuticals can be contaminated by potentially dangerous substances Essential to establish adequate cleaning procedures Validation Why cleaning validation is so important (2) “Particular attention should be accorded to the validation of … cleaning procedures” (WHO) “Cleaning validation should be performed in order to confirm the effectiveness of a cleaning procedure” (PIC/S) “The data should support a conclusion that residues have been reduced to an ‘acceptable’ level” (FDA) Validation Possible contaminants Product residues Cleaning agent residues and breakdown Airborne matter Lubricants, ancillary material Decomposition residues Bacteria, mould and pyrogens Validation Strategy on cleaning validation Product contact surfaces After product changeover Between batches in campaigns Bracketing products for cleaning validation Periodic re-evaluation and revalidation Validation Cleaning validation protocol (1) Should include : Objective of the validation Responsibility for performing and approving validation study Description of equipment to be used Validation Cleaning validation protocol (2) Should include: Interval between end of production and cleaning, and commencement of cleaning procedure Cleaning procedures to be used Any routine monitoring equipment used Number of cleaning cycles performed consecutively Sampling procedures used and rationale Sampling locations (clearly defined) Validation Record of cleaning validation Should include : Data on recovery studies Analytical methods including Limit of Detection and Limit of Quantitation Acceptance criteria and rationale When revalidation will be required Must have management and QA involvement Management commitment and QA involvement Validation Results and reports Clea