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