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

Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of… Read More

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

Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability… Read More

Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the… Read More

Standard operating Procedure & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove… Read More

Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of… Read More

Guideline and Formats for Microbiological Environmental Monitoring (EM) of various area like in Production, Microbiology laboratory, Dispensing & Sampling Area,… Read More

The Microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in… Read More

Standard Operating Procedure for Cleaning and Operation of Vibro Sifter. Pharmaceutical Vibro Sifter is used to separate mass composition of solids, liquid from solid… Read More

Standard Operating Procedure for Operation and Cleaning of Tablet Compression Machine, the basic principle behind the compression machine is the… Read More