The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Validation of Manufacturing Processes Standard Operating Procedure for Validation of Manufacturing Processes 1) Purpose The purpose of this SOP is to establish procedures for the validation of manufacturing processes to ensure consistency & reliability of Manufacturing Processes. 2) Scope This SOP applies to all manufacturing processes within the facility that impact product quality,…
SOP for Training Program Standard Operating Procedure for Training Program 1) Purpose The purpose of this SOP is to establish procedures for the development, implementation, and management of a training program to ensure that personnel are competent, qualified, and compliant with job responsibilities within the manufacturing facility. 2) Scope This SOP applies to all personnel…
SOP for Change Control Standard Operating Procedure for Change Control 1) Purpose The purpose of this SOP is to establish procedures for the initiation, review, approval, implementation, and closure of change controls to ensure controlled and systematic change management within the manufacturing facility. 2) Scope This SOP applies to all changes impacting processes, equipment, facilities,…
SOP for Handling Out-of-Specification Results Standard Operating Procedure for Handling Out-of-Specification Results 1) Purpose The purpose of this SOP is to establish procedures for the identification, investigation, and handling of out-of-specification (OOS) results to ensure product quality, data integrity, and compliance with regulatory requirements. 2) Scope This SOP applies to all laboratory testing and manufacturing…
SOP for Pest Control Standard Operating Procedure for Pest Control 1) Purpose The purpose of this SOP is to establish procedures for the prevention, detection, and elimination of pests within the manufacturing facility to ensure product safety, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all areas within the manufacturing facility…
SOP for Changeover Procedures Standard Operating Procedure for Changeover Procedures 1) Purpose The purpose of this SOP is to establish procedures for the effective and efficient changeover of equipment and processes to minimize downtime, reduce product variability, and ensure compliance with regulatory requirements. 2) Scope This SOP applies to all changeover activities within the manufacturing…
SOP for Training and Competency Standard Operating Procedure for Training and Competency 1) Purpose The purpose of this SOP is to establish procedures for the training, competency assessment, and qualification of personnel to ensure competence in performing assigned tasks and responsibilities. 2) Scope This SOP applies to all personnel within the manufacturing facility who perform…
SOP for Handling of Returned Goods Standard Operating Procedure for Handling of Returned Goods 1) Purpose The purpose of this SOP is to establish procedures for the receipt, evaluation, handling, and disposition of returned goods to ensure compliance with regulatory requirements and customer satisfaction. 2) Scope This SOP applies to all returned goods received by…
SOP for Handling of Complaints Standard Operating Procedure for Handling of Complaints 1) Purpose The purpose of this SOP is to establish procedures for the receipt, evaluation, investigation, and resolution of product complaints to ensure customer satisfaction and compliance with regulatory requirements. 2) Scope This SOP applies to all complaints received by the manufacturing facility…
SOP for Change Control Standard Operating Procedure for Change Control 1) Purpose The purpose of this SOP is to establish procedures for the control, documentation, and implementation of changes to facilities, systems, equipment, processes, and documents to ensure product quality, safety, and efficacy. 2) Scope This SOP applies to all changes within the manufacturing facility…