The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Reconstitution Testing Standard Operating Procedure for Reconstitution Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting reconstitution testing of pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure that the product can be properly reconstituted prior to administration. 2) Scope This SOP…
SOP for Microbial Limits Testing for Aerosols Standard Operating Procedure for Microbial Limits Testing for Aerosols 1) Purpose The purpose of this SOP is to define procedures for conducting microbial limits testing on aerosol products to ensure compliance with microbiological quality standards and regulatory requirements. 2) Scope This SOP applies to microbial limits testing performed…
SOP for Pharmacovigilance Safety Data Exchange Agreements (SDEA) Guidelines for Pharmacovigilance Safety Data Exchange Agreements (SDEA) 1) Purpose The purpose of this SOP is to outline procedures for establishing and managing Safety Data Exchange Agreements (SDEAs) related to pharmacovigilance activities. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for negotiating, implementing, and maintaining…
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SOP for Finished Product Testing for Aerosols Standard Operating Procedure for Finished Product Testing for Aerosols 1) Purpose The purpose of this SOP is to outline procedures for conducting finished product testing on aerosol products to ensure compliance with quality specifications and regulatory standards before release for distribution. 2) Scope This SOP applies to finished…
SOP for Temperature Mapping in Storage Areas Standard Operating Procedure for Temperature Mapping in Storage Areas 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting temperature mapping in storage areas where pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, are stored to ensure that the environmental…
SOP for Product Release Testing for Aerosols Standard Operating Procedure for Product Release Testing for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for conducting product release testing on aerosol products to ensure compliance with quality standards and regulatory requirements prior to distribution. 2) Scope This SOP applies to product release…
SOP for Pharmacovigilance Product Quality Complaint Handling Guidelines for Pharmacovigilance Product Quality Complaint Handling 1) Purpose The purpose of this SOP is to outline procedures for handling product quality complaints related to pharmaceutical products. 2) Scope This SOP applies to all pharmacovigilance personnel responsible for product quality complaint handling, including pharmacovigilance managers, quality assurance officers,…
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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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