The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for External Audits by Regulatory Bodies Standard Operating Procedure for External Audits by Regulatory Bodies 1) Purpose The purpose of this SOP is to establish procedures for preparing, conducting, and responding to external audits by regulatory bodies to ensure compliance with regulatory requirements and maintain certifications. 2) Scope This SOP applies to all personnel…
SOP for Internal Audits of Manufacturing Processes Standard Operating Procedure for Internal Audits of Manufacturing Processes 1) Purpose The purpose of this SOP is to outline procedures for conducting internal audits of manufacturing processes to verify compliance with regulatory requirements, identify areas for improvement, and ensure consistent product quality. 2) Scope This SOP applies to…
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SOP for Handling and Disposal of Waste Materials from FFS Machine Standard Operating Procedure for Handling and Disposal of Waste Materials from Form-Fill-Seal (FFS) Machine 1) Purpose The purpose of this SOP is to establish procedures for the safe handling, segregation, and disposal of waste materials generated from the Form-Fill-Seal (FFS) machine operations to ensure…
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SOP for Sample Collection during FFS Operations Standard Operating Procedure for Sample Collection during Form-Fill-Seal (FFS) Operations 1) Purpose The purpose of this SOP is to define procedures for collecting representative samples during Form-Fill-Seal (FFS) operations to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in…
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SOP for Cleaning Between Batch Runs Standard Operating Procedure for Cleaning Between Batch Runs 1) Purpose The purpose of this SOP is to establish procedures for cleaning equipment and manufacturing areas between batch runs to prevent cross-contamination, ensure product quality, and maintain compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved…
SOP for Seal Integrity and Leak Testing Standard Operating Procedure for Seal Integrity and Leak Testing 1) Purpose The purpose of this SOP is to establish procedures for testing the seal integrity and leakage of packaging for pharmaceutical products to ensure product sterility and quality. 2) Scope This SOP applies to all personnel involved in…
SOP for Filling Accuracy and Volume Checks Standard Operating Procedure for Filling Accuracy and Volume Checks 1) Purpose The purpose of this SOP is to outline procedures for verifying the accuracy and volume of filled products during pharmaceutical manufacturing to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies to all personnel…
SOP for Emergency Shutdown and Restart Procedures Standard Operating Procedure for Emergency Shutdown and Restart Procedures 1) Purpose The purpose of this SOP is to define the steps and protocols for safely shutting down and restarting manufacturing equipment in case of emergencies to protect personnel and minimize equipment damage. 2) Scope This SOP applies to…
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SOP for Start-Up and Shutdown Procedures for FFS Machine Standard Operating Procedure for Start-Up and Shutdown Procedures for Form-Fill-Seal (FFS) Machine 1) Purpose The purpose of this SOP is to establish guidelines for the safe and efficient start-up and shutdown of the Form-Fill-Seal (FFS) machine to ensure consistent production and equipment longevity. 2) Scope This…
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SOP for Setting Parameters for Different IV Solutions Standard Operating Procedure for Setting Parameters for Different Intravenous (IV) Solutions 1) Purpose The purpose of this SOP is to define the procedures for setting and adjusting parameters on manufacturing equipment for different intravenous (IV) solutions to ensure product quality and consistency. 2) Scope This SOP applies…
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