The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Light Exposure Testing for Aerosols Standard Operating Procedure for Light Exposure Testing for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for conducting light exposure testing on aerosol products to evaluate product stability and degradation under light-induced conditions. 2) Scope This SOP applies to light exposure testing performed on…
SOP for Pharmacovigilance Adverse Drug Reaction (ADR) Reporting Guidelines for Pharmacovigilance Adverse Drug Reaction (ADR) Reporting 1) Purpose The purpose of this SOP is to outline procedures for the reporting of adverse drug reactions (ADRs) associated with pharmaceutical products. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for ADR reporting, including pharmacovigilance managers,…
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SOP for Freeze-Thaw Stability Testing for Aerosols Standard Operating Procedure for Freeze-Thaw Stability Testing for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for conducting freeze-thaw stability testing on aerosol products to evaluate product integrity and performance under freezing and thawing conditions. 2) Scope This SOP applies to freeze-thaw stability testing…
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SOP for Packaging Integrity Testing Standard Operating Procedure for Packaging Integrity Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting packaging integrity testing of pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure that the packaging provides adequate protection to the product. 2) Scope…
SOP for Temperature Cycling Testing for Aerosols Standard Operating Procedure for Temperature Cycling Testing for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for conducting temperature cycling testing on aerosol products to evaluate product stability and performance under varied temperature conditions. 2) Scope This SOP applies to temperature cycling testing performed…
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SOP for Pharmacovigilance Adverse Event (AE) Reporting Guidelines for Pharmacovigilance Adverse Event (AE) Reporting 1) Purpose The purpose of this SOP is to outline procedures for the reporting of adverse events (AEs) associated with pharmaceutical products. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for AE reporting, including pharmacovigilance managers, safety scientists, and…
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SOP for Compatibility Testing of Aerosols with Packaging Materials Standard Operating Procedure for Compatibility Testing of Aerosols with Packaging Materials 1) Purpose The purpose of this SOP is to establish procedures for conducting compatibility testing between aerosol products and packaging materials to ensure product stability, integrity, and safety throughout the shelf life. 2) Scope This…
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SOP for Bioburden Testing Standard Operating Procedure for Bioburden Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting bioburden testing of pharmaceutical formulations, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure the microbial quality and safety of the product. 2) Scope This SOP applies to…
SOP for Pharmacovigilance Serious Adverse Event (SAE) Management Guidelines for Pharmacovigilance Serious Adverse Event (SAE) Management 1) Purpose The purpose of this SOP is to outline procedures for the management and reporting of serious adverse events (SAEs) related to pharmaceutical products. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for SAE management, including…
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SOP for Leak Testing of Aerosol Containers Standard Operating Procedure for Leak Testing of Aerosol Containers 1) Purpose The purpose of this SOP is to establish procedures for conducting leak testing on aerosol containers to ensure product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to the leak testing of aerosol…