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Quality IT

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

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

Equipment Qualification Procedure and Protocol

Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality… Read More

Out of Specification (OOS) Handling Procedure

Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different… Read More

Stability Chamber / Incubator Management Procedure

Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to… Read More

Audit Trail Review – Procedure and Schedule

Standard Operating Procedure (SOP) for Audit Trail Review for the application software on computer system associated with laboratory instruments. Audit… Read More