Laboratory Controls.pptx - cGMPs I Laboratory Controls...

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cGMP’s I. Laboratory Controls
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Subpart I: 211.160 General Requirements Specs, standards, test methods, etc must be reviewed and approved by Quality Control Unit Deviations recorded and justified Laboratory controls scientifically sound and appropriate
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Laboratory Controls Must include: Conformance to specifications for: Components, containers, closures, labeling In-process materials Drug products Laboratory instruments must be calibrated
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211.165 Testing and Release for Distribution For each batch, assure conformance to final specifications No objectionable organisms Sampling plans in writing Sampled and tested with statistical QC criteria Accuracy, sensitivity, specificity, reproducibility of test methods Rejection of failing material
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Stability Testing Program to test stability Used to set storage conditions and expiration dates Program to include
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  • Fall '16
  • Richard Kinsey
  • Type I and type II errors, Test method, Standard

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