The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Validation of Processes Standard Operating Procedure for Validation of Processes 1) Purpose The purpose of this SOP is to establish procedures for the validation of processes, including equipment, systems, and methods, to ensure consistency, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all processes within the manufacturing facility that…
SOP for Handling of Deviations Standard Operating Procedure for Handling of Deviations 1) Purpose The purpose of this SOP is to establish procedures for handling and investigating deviations from established processes, procedures, and specifications to ensure product quality and compliance. 2) Scope This SOP applies to all deviations identified within the manufacturing facility that may…
SOP for Calibration of Equipment Standard Operating Procedure for Calibration of Equipment 1) Purpose The purpose of this SOP is to establish procedures for the calibration of equipment used in the manufacturing process to ensure accuracy, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all equipment within the manufacturing facility that…
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SOP for Internal Audits Standard Operating Procedure for Internal Audits 1) Purpose The purpose of this SOP is to establish a procedure for conducting internal audits to ensure compliance with regulatory requirements, internal policies, and quality standards. 2) Scope This SOP applies to all areas and processes within the manufacturing facility that are subject to…
SOP for Training and Competency Standard Operating Procedure for Training and Competency 1) Purpose The purpose of this SOP is to establish a procedure for training and assessing the competency of personnel to ensure they have the necessary knowledge and skills to perform their duties effectively and comply with regulatory requirements. 2) Scope This SOP…
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SOP for Risk Management Standard Operating Procedure for Risk Management 1) Purpose The purpose of this SOP is to establish a procedure for the identification, assessment, and management of risks to ensure the quality and safety of pharmaceutical products. 2) Scope This SOP applies to all processes, procedures, equipment, and systems within the manufacturing facility…
SOP for Environmental Monitoring Standard Operating Procedure for Environmental Monitoring 1) Purpose The purpose of this SOP is to establish procedures for the monitoring of environmental conditions within the manufacturing facility to ensure compliance with regulatory requirements and to maintain product quality. 2) Scope This SOP applies to all areas within the manufacturing facility that…
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SOP for Cleaning and Sanitation Standard Operating Procedure for Cleaning and Sanitation 1) Purpose The purpose of this SOP is to establish procedures for the cleaning and sanitation of the manufacturing facility and equipment to ensure a hygienic environment and prevent contamination of pharmaceutical products. 2) Scope This SOP applies to all areas within the…
SOP for Handling Customer Complaints Standard Operating Procedure for Handling Customer Complaints 1) Purpose The purpose of this SOP is to establish a procedure for the effective handling of customer complaints to ensure timely resolution and continuous improvement of product quality and customer satisfaction. 2) Scope This SOP applies to all customer complaints related to…
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SOP for Change Control Management Standard Operating Procedure for Change Control Management 1) Purpose The purpose of this SOP is to establish a procedure for managing changes to processes, procedures, equipment, and systems to ensure continued compliance with regulatory requirements and quality standards. 2) Scope This SOP applies to all changes that may impact the…
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