The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Computer System Validation Standard Operating Procedure for Computer System Validation 1) Purpose This SOP outlines the procedures for validating computer systems used in pharmaceutical manufacturing, testing, control, and documentation processes to ensure data integrity, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all computerized systems that manage or control…
SOP for Equipment Qualification (IQ/OQ/PQ) Standard Operating Procedure for Equipment Qualification (IQ/OQ/PQ) 1) Purpose This SOP outlines the procedures for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment to ensure that equipment is properly installed, operates as intended, and consistently produces results meeting predefined specifications. 2) Scope This SOP applies to…
SOP for Cleaning Validation Standard Operating Procedure for Cleaning Validation 1) Purpose This SOP outlines the procedures for conducting cleaning validation studies to ensure that cleaning procedures effectively remove residues of products, cleaning agents, and microbial contaminants from equipment surfaces to prevent cross-contamination and ensure product quality and safety. 2) Scope This SOP applies to…
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SOP for Process Validation Standard Operating Procedure for Process Validation 1) Purpose This SOP outlines the procedures for conducting process validation studies to ensure that manufacturing processes consistently produce pharmaceutical products meeting predefined quality attributes and specifications. 2) Scope This SOP applies to all stages of process validation, including process design, qualification, and continued process…
SOP for Validation Master Plan Standard Operating Procedure for Validation Master Plan 1) Purpose This SOP outlines the procedures for developing and maintaining a Validation Master Plan (VMP) to ensure that all validation activities are planned, executed, documented, and controlled in a systematic manner to demonstrate compliance with regulatory requirements and ensure the reliability of…
SOP for Training and Competency Assessment Standard Operating Procedure for Training and Competency Assessment 1) Purpose This SOP outlines the procedures for identifying training needs, conducting training programs, assessing competency, and maintaining records to ensure that all personnel are adequately trained and competent to perform their assigned tasks in compliance with regulatory requirements. 2) Scope…
SOP for Good Documentation Practices (GDP) Standard Operating Procedure for Good Documentation Practices (GDP) 1) Purpose This SOP outlines the principles and guidelines for maintaining accurate, complete, and traceable documentation throughout all stages of pharmaceutical manufacturing, ensuring data integrity, compliance with regulatory requirements, and support for quality assurance activities. 2) Scope This SOP applies to…
SOP for Documentation Control Standard Operating Procedure for Documentation Control 1) Purpose This SOP outlines the procedures for the creation, review, approval, distribution, and maintenance of documents to ensure consistency, accuracy, accessibility, and compliance with regulatory requirements. 2) Scope This SOP applies to all departments and personnel involved in creating, reviewing, approving, distributing, and maintaining…
SOP for Quality Risk Management Standard Operating Procedure for Quality Risk Management 1) Purpose This SOP outlines the procedures for implementing a systematic approach to quality risk management (QRM) to assess, control, communicate, and review risks associated with pharmaceutical operations, ensuring patient safety, product quality, and regulatory compliance. 2) Scope This SOP applies to all…
SOP for Internal Quality Audits Standard Operating Procedure for Internal Quality Audits 1) Purpose This SOP outlines the procedures for conducting internal quality audits to assess compliance with established quality management systems, identify areas for improvement, and ensure adherence to regulatory requirements. 2) Scope This SOP applies to all departments and functions within the company…