The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Internal Audits Standard Operating Procedure for Internal Audits 1) Purpose The purpose of this SOP is to establish procedures for planning, conducting, and reporting internal audits to verify compliance with regulatory requirements, quality standards, and organizational policies within the organization. 2) Scope This SOP applies to all departments and functions within the organization…
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, maintenance, and verification of equipment to ensure accuracy, reliability, and compliance with regulatory requirements within the organization. 2) Scope This SOP applies to all departments and personnel responsible for…
SOP for Product Complaint Handling Standard Operating Procedure for Product Complaint Handling 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, regulatory compliance, and continuous improvement. 2) Scope This SOP applies to all departments and personnel within the organization…
SOP for Non-Conformance Management Standard Operating Procedure for Non-Conformance Management 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of non-conformances to prevent recurrence and ensure continuous improvement within the organization. 2) Scope This SOP applies to all departments and processes within the organization that may…
SOP for Training Records and Documentation Standard Operating Procedure for Training Records and Documentation 1) Purpose The purpose of this SOP is to establish procedures for the creation, maintenance, and control of training records and documentation to ensure personnel are adequately trained and qualified to perform their assigned responsibilities. 2) Scope This SOP applies to…
SOP for Document Control Standard Operating Procedure for Document Control 1) Purpose The purpose of this SOP is to establish procedures for the control, distribution, revision, and archiving of documents to ensure accuracy, accessibility, and compliance with regulatory requirements within the organization. 2) Scope This SOP applies to all departments and functions within the organization…
SOP for Supplier Qualification and Management Standard Operating Procedure for Supplier Qualification and Management 1) Purpose The purpose of this SOP is to establish procedures for the qualification, selection, evaluation, and management of suppliers to ensure a consistent supply of materials and services that meet quality and regulatory requirements. 2) Scope This SOP applies to…
SOP for Change Management Standard Operating Procedure for Change Management 1) Purpose The purpose of this SOP is to establish procedures for the management of changes to facilities, equipment, materials, processes, and documentation to ensure controlled and effective change management within the manufacturing facility. 2) Scope This SOP applies to all departments and functions within…
SOP for Handling Deviations Standard Operating Procedure for Handling Deviations 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations from established processes or procedures to ensure product quality, compliance, and continuous improvement. 2) Scope This SOP applies to all departments and processes within the…
SOP for Handling Customer Complaints Standard Operating Procedure for Handling Customer Complaints 1) Purpose The purpose of this SOP is to establish procedures for the receipt, documentation, investigation, and resolution of customer complaints to ensure timely and effective handling, customer satisfaction, and continuous improvement. 2) Scope This SOP applies to all departments involved in the…