Production

cGMP Checklist Checklist / Formats Environment Health & Safety (EHS) Production Production Sop QA Sop QC Sop SOPs Validation
  • September 9, 2020
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New Product Introduction (Risk Evaluation)

This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment.

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Audit cGMP Checklist Checklist / Formats Doc Environment Health & Safety (EHS) Maintenance Sops Micro Sop Microbiology Production Production Sop QA Sop QC Sop Quality Control SOPs Sterile Validation
  • August 31, 2020
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Cross Contamination, Mix-Ups & Microbial Contamination

Standard Operating Procedure (SOP) and Detailed Risk Assessment approach for Prevention of Cross Contamination, Mix-ups, and Microbial Contamination. Download SOP.

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Audit cGMP Doc GLP Maintenance Sops Micro Sop Microbiology Production Production Sop Protocol QA Sop QC Sop Quality Control Research SOPs Uncategorized
  • August 27, 2020
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Good Documentation Practices – SOP & Guideline

Standard Operating Procedure (SOP) cum Guideline for Good Documentation Practices for cGxP documents (Electronic and Handwritten) Pharmaceutical Drug Manufacturing Plants..

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Calibration cGMP GLP Production Production Sop QA Sop SOPs Validation
  • August 19, 2020
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Calibration Program – SOP & Policy

Standard Operating Procedure (SOP) and Policy/Program for Calibration of Instrument, Equipment, and Measuring Device used to measurement, monitoring, and controlling.

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cGMP GLP Micro Sop Production Production Sop Protocol QA Sop QC Sop Quality Control SOPs Sterile Validation
  • August 15, 2020
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Process Standardization and Validation – SOP

Standard Operating Procedure (SOP) for Process Standardization and Validation be carried for the new products and existing products at the.

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cGMP Microbiology Production Production Sop QA Sop QC Sop Quality Control SOPs Sterile Stores Sops
  • August 12, 2020
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Batch Release Procedure of Finished Product

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply.

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cGMP Checklist GLP Maintenance Sops Micro Sop Microbiology Production Production Sop QA Sop QC Sop Quality Control SOPs Sterile Stores Sops Uncategorized
  • August 8, 2020
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Handling Power Failure Situation (SOP) in Plant

Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc.

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cGMP Environment Maintenance Sops Micro Sop Microbiology Production Production Sop QC Sop Quality Control SOPs Sterile Validation
  • August 5, 2020
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Media Fill Validation – SOP for Process Simulation

Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility.  A “media fill” (sometimes known as a “process simulation”).

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cGMP Maintenance Sops Micro Sop Microbiology Production Production Sop Protocol SOPs Sterile Validation

HVAC System Qualification Protocol (Validation)

Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System.

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cGMP Checklist / Formats Doc Production Production Sop QA Sop QC Sop Quality Control SOPs Stores Sops

Pharmacopoeial Change Management SOP

Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in.

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