The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Melting Point Determination Procedure for Melting Point Determination 1) Purpose The purpose of this SOP is to outline the procedure for determining the melting point of pharmaceutical substances using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical substances within the facility that require melting point determination as part of quality…
SOP for Volatile Oil Content Testing Procedure for Volatile Oil Content Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining the volatile oil content in pharmaceutical substances and products using appropriate analytical methods. 2) Scope This SOP applies to all pharmaceutical substances and products within the facility that require…
SOP for Preventive Maintenance of Equipment Standard Operating Procedure for Preventive Maintenance of Equipment 1) Purpose The purpose of this SOP is to establish procedures for the preventive maintenance of manufacturing equipment to ensure optimal performance and minimize equipment downtime. 2) Scope This SOP applies to all personnel involved in the preventive maintenance of equipment…
Read More “Injectables: SOP for Preventive Maintenance of Equipment” »
SOP for Elemental Impurity Testing Procedure for Elemental Impurity Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing elemental impurities in pharmaceutical products to ensure compliance with safety and regulatory standards. 2) Scope This SOP applies to all pharmaceutical products within the facility that require elemental impurity testing as…
Read More “In-Process Control: SOP for Elemental Impurity Testing” »
SOP for Residual Solvent Testing Procedure for Residual Solvent Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining residual solvent levels in pharmaceutical products to ensure compliance with safety and regulatory requirements. 2) Scope This SOP applies to all pharmaceutical products within the facility that require residual solvent testing…
Read More “In-Process Control: SOP for Residual Solvent Testing” »
SOP for Equipment Calibration Standard Operating Procedure for Equipment Calibration 1) Purpose The purpose of this SOP is to establish procedures for the calibration of manufacturing equipment to ensure accuracy and reliability in production processes. 2) Scope This SOP applies to all personnel involved in the calibration of equipment at [Company Name] used for the…
SOP for Water Content Determination (Karl Fischer) Procedure for Water Content Determination (Karl Fischer) 1) Purpose The purpose of this SOP is to outline the procedure for accurately determining the water content in pharmaceutical substances and products using the Karl Fischer titration method. 2) Scope This SOP applies to all pharmaceutical substances and products within…
Read More “SOP for Water Content Determination (Karl Fischer)” »
SOP for Antimicrobial Effectiveness Testing Procedure for Antimicrobial Effectiveness Testing 1) Purpose The purpose of this SOP is to outline the procedure for evaluating the effectiveness of antimicrobial preservatives in pharmaceutical products to ensure microbial control and product safety. 2) Scope This SOP applies to all pharmaceutical formulations containing antimicrobial preservatives that require antimicrobial effectiveness…
SOP for Microbial Limits Testing in Non-Sterile Products Procedure for Microbial Limits Testing in Non-Sterile Products 1) Purpose The purpose of this SOP is to outline the procedure for conducting microbial limits testing on non-sterile pharmaceutical products to ensure compliance with microbiological quality standards. 2) Scope This SOP applies to all non-sterile pharmaceutical products manufactured…
Read More “SOP for Microbial Limits Testing in Non-Sterile Products” »
SOP for Cleaning Validation Standard Operating Procedure for Cleaning Validation 1) Purpose The purpose of this SOP is to establish procedures for validating the cleaning processes of manufacturing equipment to ensure they consistently remove residues to acceptable levels. 2) Scope This SOP applies to all personnel involved in cleaning validation at [Company Name] for the…