Operation and Calibration of Friability Test Apparatus SOP
SOP for Operation and Calibration of Friability Test Apparatus.
1. Precaution.
2. Operation.
3. Calibration.
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Analyst Qualification SOP
SOP for training and qualification of the Analysts in Quality Control Department
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Adjustment of Chromatographic Conditions as per BP / USP (for HPLC)
Adjustment of Chromatographic Conditions as per BP / USP for Isocratic elution and Gradient elution.
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Good Chromatographic Practices SOP
SOP for Good Chromatographic Practices.
1. Definitions.
2. Analysis.
3. Integration.
4. Documentation and review.
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Audit Trail SOP
SOP for Audit Trail (HPLC systems having LAB SOLUTION software)
1. 21 CFR part 11.
2. Purpose.
3. Integration.
Investigating and Handling of Out Of Trend (OOT) Test Results SOP
SOP for Investigating and Handling of Out Of Trend (OOT) Test Results.
1. Definition
2. Investigating and Handling
3. Annexures
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Investigating and Handling Of Out Of Specification (OOS) Test Results SOP
SOP for investigating and handling of Out of Specification (OOS).
1. Definitions
2. Investigation and handling
3. Flowchart
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Handling of Out Of Calibration (OOC) SOP
SOP for Handling of Out Of Calibration. 1. Definition
2. investigation
3. Handling of Out of Calibration
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Handling of The Spillage SOP
SOP for handling the spillages in the laboratory.
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Usage Entry on Log Books SOP
SOP for Usage Entry on Log Books
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