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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Guideline for Equipment and System Qualification

Standard Operating Procedure (SOP) and Guideline for preparation of Equipment / System Qualification  (URS, IQ, OQ, PQ, FAT, SAT, etc.) documents, execution of Qualification activities, Review and Compilation of data,…

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