Tag: Training and Competency Assessment SOP

Quality Assurance: SOP for Change Control Management

SOP for Change Control Management Standard Operating Procedure for Change Control Management 1) Purpose This SOP outlines the procedures for initiating, evaluating, implementing, and documenting changes to processes, systems, facilities, equipment, and documents to ensure controlled and systematic change management while maintaining compliance with regulatory requirements. 2) Scope This SOP applies to all departments and…

Quality Assurance

SOP for CAPA (Corrective and Preventive Actions)

SOP for CAPA (Corrective and Preventive Actions) Standard Operating Procedure for CAPA (Corrective and Preventive Actions) 1) Purpose This SOP outlines the procedures for initiating, investigating, implementing, and verifying corrective and preventive actions (CAPA) to address non-conformances, deviations, and potential issues in order to prevent their recurrence. 2) Scope This SOP applies to all departments…

Quality Assurance

Quality Assurance: SOP for Handling Deviations

SOP for Handling Deviations Standard Operating Procedure for Handling Deviations 1) Purpose This SOP outlines the procedures for identifying, documenting, investigating, and resolving deviations from established procedures or specifications to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies to all departments and personnel involved in the manufacturing, testing, and quality…

Quality Assurance

SOP for Vendor Audits and Assessments

SOP for Vendor Audits and Assessments Standard Operating Procedure for Vendor Audits and Assessments 1) Purpose This SOP outlines the procedures for conducting audits and assessments of vendors to ensure they comply with regulatory requirements and the company’s quality standards for the materials and services they provide. 2) Scope This SOP applies to all vendors…

Quality Assurance

SOP for Supplier Qualification and Approval

SOP for Supplier Qualification and Approval Standard Operating Procedure for Supplier Qualification and Approval 1) Purpose This SOP outlines the procedures for the qualification and approval of suppliers to ensure that all materials and services procured meet the company’s quality standards and regulatory requirements. 2) Scope This SOP applies to all suppliers of materials, components,…

Quality Assurance

SOP for Quality Assurance Audits

SOP for Quality Assurance Audits Standard Operating Procedure for Quality Assurance Audits 1) Purpose This SOP outlines the procedures for conducting quality assurance (QA) audits to ensure compliance with regulatory requirements and company standards, and to identify areas for continuous improvement. 2) Scope This SOP applies to all internal and external QA audits conducted within…

Quality Assurance

SOP for Quality Control Sample Management

SOP for Quality Control Sample Management Standard Operating Procedure for Quality Control Sample Management 1) Purpose This SOP outlines the procedures for the proper management of quality control samples, including their collection, handling, storage, and disposal, to ensure the integrity and reliability of test results. 2) Scope This SOP applies to all quality control samples…

Quality Assurance

Quality Assurance: SOP for Batch Record Review and Approval

SOP for Batch Record Review and Approval Standard Operating Procedure for Batch Record Review and Approval 1) Purpose This SOP outlines the procedures for the review and approval of batch records to ensure that each batch of pharmaceutical product is manufactured in compliance with regulatory standards and company policies before release. 2) Scope This SOP…

Quality Assurance

SOP for Finished Product Quality Assurance

SOP for Finished Product Quality Assurance Standard Operating Procedure for Finished Product Quality Assurance 1) Purpose This SOP outlines the procedures for ensuring the quality of finished pharmaceutical products before they are released for distribution to ensure they meet all regulatory and company quality standards. 2) Scope This SOP applies to all finished products manufactured…

Quality Assurance

SOP for In-process Quality Control

SOP for In-process Quality Control Standard Operating Procedure for In-process Quality Control 1) Purpose This SOP outlines the procedures for monitoring and controlling the quality of pharmaceutical products during the manufacturing process to ensure they meet specified standards and regulatory requirements. 2) Scope This SOP applies to all in-process quality control activities conducted during the…

Quality Assurance