Quality Assurance

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

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

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

Guideline for Laboratory Standard Management (Preparation, Qualification and Handling of Analytical standards/Working Standard/Primary Standard etc.) Working Standard Management 1.0   Objective… Read More

Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw… Read More

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

Standard Operating Procedure for Operating, Calibrating and Cleaning of Moisture Analyzer Balance used to determine the moisture content in bulk… Read More

Standard Operating Procedure for Operation and Cleaning of Auto Coater - Automatic Coating Machine used for Tablet Coating during manufacturing… Read More

Standard Operating Procedure and Guideline for Cleaning & Operation of Fluidized Bed Dryer (FBD) and Finger Bags (FBD Bags) which… Read More

SStandard Operating Procedure (SOP) and Guideline for Operation and Cleaning of Rapid Mixer Granulator (RMG) used in granulation section of… Read More

Guideline for In Process Quality Control (IPQC) check during manufacturing of different pharmaceutical dosage form like Oral Liquid, Tablets &… 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 (SOP) and Guideline for Handling of Out of Calibration (OOC) results of Laboratory Instruments and Equipment like… 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) for Audit Trail Review for the application software on computer system associated with laboratory instruments. Audit… Read More