Production

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

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

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

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

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

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

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

Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch… Read More

Standard Operating Procedure (SOP) for In - Process Quality Assurance (IPQA) check points and procedure during manufacturing of drug product… Read More