The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for pH Determination in Semisolids Procedure for pH Determination in Semisolids 1) Purpose The purpose of this SOP is to outline the procedure for determining the pH of semisolid pharmaceutical formulations to ensure their quality and consistency. 2) Scope This SOP applies to all semisolid formulations (e.g., creams, ointments, gels) manufactured within the facility…
SOP for Visual Inspection of Injectable Products Procedure for Visual Inspection of Injectable Products 1) Purpose The purpose of this SOP is to outline the procedure for visually inspecting injectable products to ensure they meet quality standards and are free from visible defects. 2) Scope This SOP applies to all injectable products manufactured within the…
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SOP for Leak Testing of Sealed Containers Procedure for Leak Testing of Sealed Containers 1) Purpose The purpose of this SOP is to outline the procedure for conducting leak testing on sealed containers to ensure their integrity and prevent leakage of pharmaceutical products. 2) Scope This SOP applies to all types of sealed containers (e.g.,…
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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…
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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…