The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Water System Monitoring Standard Operating Procedure for Water System Monitoring 1) Purpose This SOP outlines the procedures for monitoring the pharmaceutical water system to ensure quality and compliance with regulatory standards. 2) Scope This SOP applies to the monitoring of pharmaceutical water systems including purified water (PW), water for injection (WFI), and other…
SOP for HVAC System Maintenance Standard Operating Procedure for HVAC System Maintenance 1) Purpose The purpose of this SOP is to establish the procedures for maintaining HVAC systems to ensure they operate efficiently and comply with regulatory requirements in the pharmaceutical industry. 2) Scope This SOP applies to all HVAC systems used in the pharmaceutical…
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SOP for Compliance with Regulatory Requirements Compliance with Regulatory Requirements – Standard Operating Procedure 1) Purpose To establish guidelines for ensuring adherence to regulatory requirements governing procurement activities within the pharmaceutical purchase department. 2) Scope This SOP applies to all procurement processes and activities that impact compliance with applicable regulatory standards and guidelines. 3) Responsibilities…
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SOP for HVAC System Monitoring Standard Operating Procedure for HVAC System Monitoring 1) Purpose This SOP outlines the procedures for monitoring Heating, Ventilation, and Air Conditioning (HVAC) systems in pharmaceutical manufacturing facilities. 2) Scope This SOP applies to the monitoring of HVAC systems throughout the pharmaceutical manufacturing facility to ensure compliance with environmental control requirements….
SOP for In-process Monitoring and Control during FFS Operations Standard Operating Procedure for In-process Monitoring and Control during FFS Operations 1) Purpose The purpose of this SOP is to outline the procedures for monitoring and controlling critical parameters during Form-Fill-Seal (FFS) operations to ensure product quality and process efficiency. 2) Scope This SOP applies to…
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SOP for Emergency Maintenance Procedures Standard Operating Procedure for Emergency Maintenance Procedures 1) Purpose The purpose of this SOP is to outline the procedures for responding to emergency maintenance situations to ensure the safety, reliability, and compliance of equipment and systems in the pharmaceutical industry. 2) Scope This SOP applies to all equipment and systems…
SOP for HEPA Filter Integrity Testing Standard Operating Procedure for HEPA Filter Integrity Testing 1) Purpose This SOP outlines the procedures for conducting HEPA filter integrity testing in cleanrooms or controlled environments. 2) Scope This SOP applies to HEPA filter integrity testing conducted in cleanrooms or areas where high-efficiency particulate air (HEPA) filters are used…
SOP for Risk Management in Procurement Risk Management in Procurement – Standard Operating Procedure 1) Purpose To establish guidelines for identifying, assessing, mitigating, and managing risks associated with procurement activities within the pharmaceutical purchase department. 2) Scope This SOP applies to the proactive management of risks throughout the procurement lifecycle, from supplier selection to contract…
SOP for Maintenance Work Order Management Standard Operating Procedure for Maintenance Work Order Management 1) Purpose The purpose of this SOP is to establish the procedures for managing maintenance work orders to ensure timely and effective maintenance activities in the pharmaceutical industry. 2) Scope This SOP applies to all maintenance work orders issued for the…
SOP for Microbial Enumeration Testing Standard Operating Procedure for Microbial Enumeration Testing 1) Purpose This SOP outlines the procedures for conducting microbial enumeration testing on pharmaceutical raw materials and products. 2) Scope This SOP applies to microbial enumeration testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The…