The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Suppository Printer Operation and Maintenance of Suppository Printer 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository printer to ensure accurate printing of labels or markings on suppositories during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation,…
SOP for Propellant Testing in MDIs Propellant Testing Procedures in MDIs 1) Purpose The purpose of this SOP is to establish procedures for the testing of propellants used in metered-dose inhalers (MDIs) to ensure their quality, safety, and compatibility with product formulations. 2) Scope This SOP applies to all personnel involved in propellant testing activities…
SOP for Process Optimization for Powders Standard Operating Procedure for Process Optimization for Powders 1) Purpose The purpose of this SOP is to outline the procedures for process optimization of powder manufacturing in the pharmaceutical industry to enhance efficiency, consistency, and product quality. 2) Scope This SOP applies to all personnel involved in the process…
SOP for Ring Forming Tool Operation and Maintenance of Ring Forming Tool 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring forming tool to ensure accurate formation of rings during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…
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SOP for Pharmacovigilance Expedited Reporting Criteria Guidelines for Pharmacovigilance Expedited Reporting Criteria 1) Purpose The purpose of this SOP is to establish criteria and procedures for identifying and reporting expedited safety reports of suspected serious adverse reactions (SUSARs) to regulatory authorities within defined timelines. 2) Scope This SOP applies to personnel responsible for pharmacovigilance case…
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SOP for Gel Mixer Agitator Operation and Maintenance of Gel Mixer Agitator 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel mixer agitator to ensure thorough mixing of gel formulations during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation,…
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SOP for Formulation Development for Granules Standard Operating Procedure for Formulation Development for Granules 1) Purpose The purpose of this SOP is to outline the procedures for the formulation development of granules in the pharmaceutical industry to ensure consistency, efficacy, and compliance with regulatory standards. 2) Scope This SOP applies to all personnel involved in…
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SOP for Assay of Active Ingredient in MDIs Assay Procedures for Active Ingredient in MDIs 1) Purpose The purpose of this SOP is to establish procedures for the assay of the active ingredient in metered-dose inhalers (MDIs) to determine its concentration and ensure product quality and consistency. 2) Scope This SOP applies to all personnel…
SOP for Process Analytical Technology (PAT) Implementation Standard Operating Procedure for Process Analytical Technology (PAT) Implementation 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline procedures for the implementation of Process Analytical Technology (PAT) within the pharmaceutical manufacturing facility to enhance process understanding, control, and optimization. 2) Scope This SOP applies…
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SOP for Cream Dispensing Pump Operation and Maintenance of Cream Dispensing Pump 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream dispensing pump to ensure accurate dispensing of cream during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…
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