Microbiology

Cleaning is a crucial step in the manufacturing of pharmaceutical products, and it is essential to validate that the equipment… Read More

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

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

Procedure for Isolation and Identification of Microbial Cultures & Microbial Isolates using different Analytical Methods from the manufacturing environment of… Read More

This SOP describes the process and requirements for the transfer of analytical test method from an originating laboratory (Transferring Unit)… Read More

Standard Operating Procedure for Microbiological Analysis of Water used for manufacturing of various drug product in pharmaceutical industry. Procedure for… Read More

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

Standard operating Procedure for Subculturing (Cell Passaging) in microbiology and its maintenance. Subculturing also referred to as passaging cells, is… Read More

Standard Operating Procedure (SOP) for Microbiological Media Preparation. Media are required for cultivating the Micro-Organism. Microbiology Media should be prepared… 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 Operation Procedure (SOP) of providing training and qualification of analyst for all new appointed personnel, and existing employees who… Read More

Standard Operating Procedure (SOP) and Guideline for Preservative Efficacy Test in Microbiology Laboratory for checking of effectiveness of preservatives added… Read More

Standard Operating Procedure (SOP) for Growth Promotion Test (GPT) of Microbiological Media in Microbiology Laboratory. Growth Promotion Test (GPT) 1.0 … Read More

Standard Operating Procedure (SOP) for Handling of Out of Trend (OOT) results during Stability Study of Drug Product. Out of… Read More

Standard Operating Procedure & Guideline for Hold Time Study of Drug Product at different manufacturing stages like bulk granules/powder, blend,… Read More

Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality… Read More

Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and… Read More