SOP for Microbiological Quality Assurance

SOP for Microbiological Quality Assurance Standard Operating Procedure for Microbiological Quality Assurance 1) Purpose This SOP outlines the procedures for ensuring microbiological quality assurance of pharmaceutical products to maintain their…

Quality Assurance: SOP for Environmental Monitoring Program

SOP for Environmental Monitoring Program Standard Operating Procedure for Environmental Monitoring Program 1) Purpose This SOP outlines the procedures for conducting an environmental monitoring program to ensure that the manufacturing…

SOP for Sampling Procedures

SOP for Sampling Procedures Standard Operating Procedure for Sampling Procedures 1) Purpose This SOP outlines the procedures for sampling raw materials, intermediates, active pharmaceutical ingredients (APIs), and finished products to…

SOP for Stability Studies

SOP for Stability Studies Standard Operating Procedure for Stability Studies 1) Purpose This SOP outlines the procedures for conducting stability studies on pharmaceutical products to determine their shelf life and…

SOP for Stability Data Management

SOP for Stability Data Management Standard Operating Procedure for Stability Data Management 1) Purpose This SOP outlines the procedures for managing stability data generated from stability studies to ensure accurate…

SOP for Analytical Method Validation

SOP for Analytical Method Validation Standard Operating Procedure for Analytical Method Validation 1) Purpose This SOP outlines the procedures for validating analytical methods used in the testing of pharmaceutical products…

SOP for Computer System Validation

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)

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)…

Quality Assurance: SOP for Cleaning Validation

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…

Quality Assurance: SOP for Process Validation

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…