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Audit cGMP QA Sop SOPs

SOP for Vendor Management

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after

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Audit cGMP Doc QA Sop SOPs

Record Retention and Archival Policy

The retention period for the Documents and Records in which record shall be retained /preserved in a facility according to

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Doc QA Sop SOPs

Document Management System

A document is a physical or digital representation of a body of information designed with the capacity (and usually intent)

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cGMP Protocol QA Sop SOPs Validation

Process Validation SOP and Protocol

Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which

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cGMP Checklist / Formats Protocol QA Sop SOPs Validation

Technology Transfer of Drug Product

Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first

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cGMP GLP Quality Control SOPs

SOP for Rounding off the Analytical Test Results

Standard Operating procedure (SOP) for rounding off figures, numbers of analytical test results, including assay result rounding off, related substances

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Micro Sop Microbiology SOPs

Microbial Culture Management

A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed

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cGMP GLP Protocol QC Sop Quality Control SOPs

SOP for Reduced Testing

Standard Operating Procedure  (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity

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cGMP QA Sop SOPs

SOP for Control Sample Management

Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system

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Calibration QC Sop Quality Control SOPs Validation

Raman Analyzer – Handling Procedure (SOP)

The Development of hand-held Raman Spectrometers has drastically changed the manner of internal control for incoming raw material. Raman has

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