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  • Analyst and Reviewer Qualification Procedure

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  • Analytical Instrument – Equipment Qualification

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  • Analytical Method Transfer (AMT) procedure

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  • Contract Laboratory Agreement and Testing

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  • Electronic Signature and Audit Trail Review – Empower

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  • Good Chromatographic Practices (GCP)

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  • Handling of Extraneous Peak

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  • Handling of Out of Specification (OOS)

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  • Handling of Pharmacopoeial Changes

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  • Handling procedure Out of Trend (OOT) Test Results

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  • Laboratory Standard Management (WS,WRS Qualification)

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  • Reduce Testing Procedure for Raw Material

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