Drug Product (Finished, Stability) Sampling Procedure

Standard Operating Procedure (SOP) for the sampling/collection of trial, in-process, Finished product, micro, hold time, validation, control, and stability sample. SOP for Drug Product Sampling 1.0   PURPOSE: To define the…

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Handling of Outliers in Near Infrared (NIR) Analysis

Standard Operating Procedure (SOP) & guideline for the Handling of Outliers or aberrant or Out of Specification test result in Near Infrared (NIR) Analysis. Handling of Outliers in Near Infrared…

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Contract Laboratory Agreement and Testing SOP

Standard Operating Procedure (SOP) for Contract Laboratory Agreement and analytical testing. It covers all the processes of sample sending, sample analysis, and report review of the contract testing laboratory. Contract…

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