The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Leak Testing of Transdermal Patch Packages Standard Operating Procedure for Leak Testing of Transdermal Patch Packages 1) Purpose To establish a standardized procedure for performing leak testing on transdermal patch packages to ensure package integrity and product stability. 2) Scope This SOP applies to the quality control (QC) department responsible for conducting leak…
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SOP for Tablet Coating Machine Operation and Maintenance of Tablet Coating Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet coating machine to ensure the production of coated tablets with uniform quality and appearance. 2) Scope This SOP applies to all personnel involved in the…
SOP for Particle Size Analysis in Lotions Standard Operating Procedure for Particle Size Analysis of Lotions 1) Purpose The purpose of this SOP is to outline the procedure for conducting particle size analysis of lotions to ensure uniformity and consistency in product quality. 2) Scope This SOP applies to all personnel involved in the particle…
SOP for Packaging Component Testing for Transdermal Patches Standard Operating Procedure for Packaging Component Testing for Transdermal Patches 1) Purpose To establish procedures for testing and qualifying packaging components used for packaging transdermal patches, ensuring their compatibility and suitability for maintaining product integrity and stability. 2) Scope This SOP applies to the quality control (QC)…
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SOP for Aseptic Media Fill Trials for IM and SC Injections Standard Operating Procedure for Aseptic Media Fill Trials for IM and SC Injections 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting aseptic media fill trials to validate the aseptic filling process for Intramuscular (IM) and…
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SOP for pH Testing of Lotions Standard Operating Procedure for Lotion pH Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting pH testing of lotions to ensure the product maintains the desired pH range for safety and efficacy. 2) Scope This SOP applies to all personnel involved in the…
SOP for Stability-Indicating Methods Development for Transdermal Patches Standard Operating Procedure for Stability-Indicating Methods Development for Transdermal Patches 1) Purpose To establish procedures for developing and validating stability-indicating analytical methods for assessing the stability of active pharmaceutical ingredients (APIs) and formulations in transdermal patches. 2) Scope This SOP applies to the analytical development and quality…
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SOP for Suppository Filling and Sealing Machine Operation and Maintenance of Suppository Filling and Sealing Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository filling and sealing machine to ensure the production of high-quality suppositories. 2) Scope This SOP applies to all personnel involved in…
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SOP for Stability-Indicating Methods Development for Transdermal Patches Standard Operating Procedure for Stability-Indicating Methods Development for Transdermal Patches 1) Purpose To establish procedures for developing and validating stability-indicating analytical methods for assessing the stability of active pharmaceutical ingredients (APIs) and formulations in transdermal patches. 2) Scope This SOP applies to the analytical development and quality…
SOP for Pharmacovigilance Metrics and Key Performance Indicators (KPIs) Guidelines for Pharmacovigilance Metrics and KPIs 1) Purpose The purpose of this SOP is to outline the procedures for defining, collecting, analyzing, and reporting pharmacovigilance metrics and key performance indicators (KPIs) to ensure the effectiveness and efficiency of pharmacovigilance activities. 2) Scope This SOP applies to…
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