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cGMP Checklist / Formats GLP Micro Sop Microbiology Production Protocol QA Sop QC Sop Quality Control SOPs Sterile Validation
  • October 10, 2020
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Disinfectants & Sanitizer Efficacy Testing Protocol

This protocol/SOP is designed to establish the scientific evidence and demonstrate the efficacy of disinfectants and sanitizing agents against various

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cGMP GLP Micro Sop Microbiology Production Production Sop QA Sop QC Sop Quality Control SOPs Validation
  • October 9, 2020
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Drug Product (Finished, Stability) Sampling Procedure

Standard Operating Procedure (SOP) for the sampling/collection of trial, in-process, Finished product, micro, hold time, validation, control, and stability sample.

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Calibration cGMP Checklist Checklist / Formats GLP Protocol QC Sop Quality Control SOPs Stores Sops
  • October 8, 2020
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Handling of Outliers in Near Infrared (NIR) Analysis

Standard Operating Procedure (SOP) & guideline for the Handling of Outliers or aberrant or Out of Specification test result in

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cGMP Checklist Maintenance Sops Production Production Sop Protocol QA Sop SOPs Validation
  • October 7, 2020
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Guideline for Equipment and System Qualification

Standard Operating Procedure (SOP) and Guideline for preparation of Equipment / System Qualification  (URS, IQ, OQ, PQ, FAT, SAT, etc.)

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cGMP Environment Health & Safety (EHS) Maintenance Sops QA Sop SOPs
  • October 6, 2020
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Water Storage Tank – Procedure for Cleaning

Standard Operating Procedure (SOP) for cleaning of the water storage tank (Fire Hydrant, Soft Water, RO water) in the pharmaceutical

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cGMP Production Production Sop QA Sop SOPs Sterile
  • October 5, 2020
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Yield Fixation and Evaluation at Different Processing Stages

Standard Operating Procedure (SOP) for the Calculation of  Yield and finalize the Limit at the different stages of drug product

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cGMP Checklist Checklist / Formats Environment Health & Safety (EHS) Maintenance Sops SOPs
  • October 3, 2020
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Fire System – Operation and Maintenance SOP

Standard Operating Procedure (SOP) to lay down a procedure to describe the operation and maintenance of the fire System. It

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Audit Checklist / Formats QA Sop QC Sop SOPs Sterile
  • October 2, 2020
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Contract Laboratory Agreement and Testing SOP

Standard Operating Procedure (SOP) for Contract Laboratory Agreement and analytical testing. It covers all the processes of sample sending, sample

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Audit Calibration cGMP Checklist Checklist / Formats Doc GC Health & Safety (EHS) HPLC Maintenance Sops Micro Sop Microbiology Production Production Sop Protocol QA Sop QC Sop SOPs Sterile Stores Sops
  • October 1, 2020
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Investigation Tools used in Pharma – SOP & Guideline

The investigation related to quality-related events that occur from cGxPs approved specifications, and/or procedures including but not limited to Protocols,

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cGMP Production Production Sop QA Sop QC Sop SOPs Stores Sops
  • September 30, 2020
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Handling of Returned Raw & Packing Material – SOP

Standard Operating Procedure (SOP) for Handling of Raw material and Packing Material returned from different sections of the manufacturing/production department

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