The Ultimate Resource for Pharmaceutical SOPs and Best Practices
In-process testing plays a pivotal role in pharmaceutical manufacturing, ensuring the quality, safety, and efficacy of pharmaceutical products. By conducting various tests throughout the manufacturing process, manufacturers can monitor critical parameters and identify any deviations or issues early on. In-process testing allows for real-time monitoring of key quality attributes such as content uniformity, dissolution rates, and microbiological purity, among others. This proactive approach helps to prevent defects, minimize batch failures, and ensure that products consistently meet regulatory requirements and quality standards. Moreover, in-process testing enables manufacturers to implement corrective actions promptly, improving process efficiency and reducing the risk of producing substandard or unsafe products. Ultimately, the importance of in-process testing in pharmaceuticals lies in its ability to uphold product quality, safeguard patient health, and maintain the integrity of the pharmaceutical industry as a whole.
SOP for HEPA Filter Integrity Testing Procedure for HEPA Filter Integrity Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting HEPA (High Efficiency Particulate Air) filter integrity testing to ensure air quality in cleanrooms. 2) Scope This SOP applies to all HEPA filters installed in cleanrooms within the facility…
Read More “In-Process Control: SOP for HEPA Filter Integrity Testing” »
SOP for Aseptic Process Simulation (Media Fill) Procedure for Aseptic Process Simulation (Media Fill) 1) Purpose The purpose of this SOP is to outline the procedure for conducting aseptic process simulations (media fills) to validate the aseptic manufacturing process. 2) Scope This SOP applies to all aseptic manufacturing processes within the facility that require validation…
Read More “SOP for Aseptic Process Simulation (Media Fill)” »
SOP for Terminal Sterilization Validation Procedure for Terminal Sterilization Validation 1) Purpose The purpose of this SOP is to outline the procedure for validating terminal sterilization processes for pharmaceutical products to ensure microbial safety. 2) Scope This SOP applies to all pharmaceutical products within the facility that undergo terminal sterilization as part of the manufacturing…
SOP for Extractable Volume Testing in Parenterals Procedure for Extractable Volume Testing in Parenterals 1) Purpose The purpose of this SOP is to outline the procedure for determining the extractable volume of parenteral containers using appropriate analytical techniques. 2) Scope This SOP applies to all parenteral containers within the facility that require extractable volume testing…
Read More “SOP for Extractable Volume Testing in Parenterals” »
SOP for Ash Content Determination Procedure for Ash Content Determination 1) Purpose The purpose of this SOP is to outline the procedure for determining the ash content of pharmaceutical substances using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical substances within the facility that require ash content determination as part of quality…
SOP for Loss on Drying Testing Procedure for Loss on Drying Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining the loss on drying of pharmaceutical substances using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical substances within the facility that require loss on drying testing…
SOP for Angle of Repose Testing Procedure for Angle of Repose Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining the angle of repose of pharmaceutical powders using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical powders within the facility that require angle of repose testing…
SOP for Powder Density Testing Procedure for Powder Density Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining the powder density of pharmaceutical substances using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical powders within the facility that require powder density testing as part of quality…
SOP for Bulk Powder Uniformity Testing Procedure for Bulk Powder Uniformity Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting bulk powder uniformity testing in pharmaceutical substances using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical powders within the facility that require bulk powder uniformity testing…
SOP for Optical Rotation Testing Procedure for Optical Rotation Testing 1) Purpose The purpose of this SOP is to outline the procedure for determining the optical rotation of pharmaceutical substances using appropriate analytical techniques. 2) Scope This SOP applies to all pharmaceutical substances within the facility that require optical rotation testing as part of quality…