The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
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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…
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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…
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SOP for Particulate Matter Testing in Liquids Procedure for Particulate Matter Testing in Liquids 1) Purpose The purpose of this SOP is to outline the procedure for testing particulate matter in liquid samples used in pharmaceutical manufacturing to ensure product quality and safety. 2) Scope This SOP applies to all liquid formulations produced within the…
SOP for Specific Gravity Testing of Liquids Procedure for Specific Gravity Testing of Liquids 1) Purpose The purpose of this SOP is to outline the procedure for measuring the specific gravity of liquid samples used in pharmaceutical manufacturing to ensure accurate density determination. 2) Scope This SOP applies to all liquid formulations produced within the…