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…
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)…
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…
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…
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…
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,…
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…
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,…
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…
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…