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Quality Assurance

This category includes Quality Assurance SOP’s.

Calibration of Instrument / Equipment Policy

Calibration Policy/SOP - Instrument calibration is one of the primary processes used to maintain instrument accuracy. Calibration is the process of… Read More

Media Fill Validation Procedure & Guideline

A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of… Read More

Work Permit System (Safety)

Safety work permit is a written record that authorizes specific work, at a specific location, for a specific time period.… Read More

Top Loading Balance – Operation and Calibration SOP

Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of… Read More

Data Integrity Incident Handling Procedure

Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of… Read More

Transport Validation – Guideline & Protocol

Standard Operating Procedure (SOP) and Protocol for Transport Validation through temperature mapping during transit of drug products. Transport Validation Procedure… Read More

Documents and Data Control in Pharmaceuticals

Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose… Read More

Reprocessing Reworking & Redressing of Product

Reprocessing and reworking are considered non-routine events. Reprocessing: reprocessing is the introduction of an in-process material or drug product including… Read More

Tech Transfer Documents Handling Procedure

Standard Operating Procedure for the handling of Tech Transfer documents received from transferring unit (TU)/ generated at receiving unit (RU)… Read More

Reduce Testing Procedure for Raw Material (API)

Standard Operating Procedure (SOP) for Reduce Testing in pharmaceutical starting materials (Raw Material) procured from approved vender. Reduce Testing Procedure… Read More