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 Container Closure Integrity Testing Procedure for Container Closure Integrity Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting container closure integrity (CCI) testing to ensure the integrity of sealed containers used for pharmaceutical products. 2) Scope This SOP applies to all pharmaceutical products packaged in containers sealed…
SOP for Content Uniformity in Capsules Procedure for Content Uniformity in Capsules 1) Purpose The purpose of this SOP is to outline the procedure for testing content uniformity in filled capsules to ensure each capsule contains the correct amount of active pharmaceutical ingredient (API) within specified limits. 2) Scope This SOP applies to all capsule…
SOP for Content Uniformity in Tablets Procedure for Content Uniformity in Tablets 1) Purpose The purpose of this SOP is to outline the procedure for testing content uniformity in finished tablets to ensure each tablet contains the correct amount of active pharmaceutical ingredient (API) within specified limits. 2) Scope This SOP applies to all tablet…
SOP for Impurity Profiling Procedure for Impurity Profiling 1) Purpose The purpose of this SOP is to outline the procedure for conducting impurity profiling of Active Pharmaceutical Ingredients (APIs) to ensure their purity and compliance with regulatory standards. 2) Scope This SOP applies to all APIs used in pharmaceutical manufacturing within the facility that require…
SOP for Assay Testing of Active Pharmaceutical Ingredient (API) Procedure for Assay Testing of Active Pharmaceutical Ingredient (API) 1) Purpose The purpose of this SOP is to outline the procedure for conducting assay testing on Active Pharmaceutical Ingredients (APIs) to ensure their potency and quality meet specified standards. 2) Scope This SOP applies to all…
Read More “SOP for Assay Testing of Active Pharmaceutical Ingredient (API)” »
SOP for Pyrogen Testing Procedure for Pyrogen Testing 1) Purpose The purpose of this SOP is to outline the procedure for performing pyrogen testing on pharmaceutical products to ensure they are free from pyrogenic contaminants and safe for patient use. 2) Scope This SOP applies to all pharmaceutical products manufactured within the facility that require…
SOP for Sterility Testing Procedure for Sterility Testing 1) Purpose The purpose of this SOP is to outline the procedure for performing sterility testing on pharmaceutical products to ensure they are free from viable microorganisms and safe for patient use. 2) Scope This SOP applies to all pharmaceutical products manufactured within the facility that require…
SOP for Endotoxin Testing in Injectable Products Procedure for Endotoxin Testing in Injectable Products 1) Purpose The purpose of this SOP is to outline the procedure for conducting endotoxin testing on injectable products to ensure compliance with regulatory requirements and patient safety. 2) Scope This SOP applies to all injectable products manufactured within the facility…
Read More “SOP for Endotoxin Testing in Injectable Products” »
SOP for Osmolality Testing Procedure for Osmolality Testing 1) Purpose The purpose of this SOP is to outline the procedure for measuring the osmolality of liquid samples used in pharmaceutical manufacturing to ensure proper formulation and patient safety. 2) Scope This SOP applies to all liquid formulations produced within the manufacturing facility that require osmolality…
SOP for Clarity and Opalescence Testing of Liquids Procedure for Clarity and Opalescence Testing of Liquids 1) Purpose The purpose of this SOP is to outline the procedure for evaluating the clarity and opalescence of liquid samples used in pharmaceutical manufacturing to ensure visual quality and compliance. 2) Scope This SOP applies to all liquid…
Read More “SOP for Clarity and Opalescence Testing of Liquids” »