The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Tablet Filler Operation and Maintenance of Tablet Filler 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet filler to ensure accurate filling of tablets during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…
SOP for Homogeneity Testing in MDIs Homogeneity Testing Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for conducting homogeneity testing of metered-dose inhalers (MDIs) to ensure uniform distribution of active ingredients throughout the product batch. 2) Scope This SOP applies to all personnel involved in homogeneity testing activities within…
SOP for Final Product Inspection for Granules Standard Operating Procedure for Final Product Inspection for Granules 1) Purpose The purpose of this SOP is to define procedures for conducting final product inspection of granules in the pharmaceutical industry to ensure compliance with quality standards and specifications before release. 2) Scope This SOP applies to all…
SOP for Suppository Transfer Conveyor Operation and Maintenance of Suppository Transfer Conveyor 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository transfer conveyor to ensure efficient and safe transfer of suppositories during manufacturing processes. 2) Scope This SOP applies to all personnel involved in the operation,…
SOP for Pharmacovigilance Seriousness Assessment Guidelines for Pharmacovigilance Seriousness Assessment 1) Purpose The purpose of this SOP is to provide guidelines for assessing the seriousness of adverse events reported in pharmacovigilance to determine appropriate regulatory reporting and risk management actions. 2) Scope This SOP applies to personnel responsible for pharmacovigilance case assessment and seriousness determination…
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SOP for Final Product Inspection for Powders Standard Operating Procedure for Final Product Inspection for Powders 1) Purpose The purpose of this SOP is to define procedures for conducting final product inspection of powders in the pharmaceutical industry to ensure compliance with quality standards and specifications before release. 2) Scope This SOP applies to all…
SOP for Ring Sterilizer Operation and Maintenance of Ring Sterilizer 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring sterilizer to ensure effective sterilization of rings used in manufacturing. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the…
SOP for IT Systems Validation and Data Integrity Standard Operating Procedure for IT Systems Validation and Data Integrity 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the validation and maintenance of IT systems within the pharmaceutical manufacturing facility to ensure data integrity, security, and compliance with regulatory requirements….
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SOP for Sample Collection for Quality Testing in MDIs Sample Collection Procedures for Quality Testing in MDIs 1) Purpose The purpose of this SOP is to establish procedures for the collection of samples during the manufacturing of metered-dose inhalers (MDIs) for subsequent quality testing to ensure product quality and compliance with specifications. 2) Scope This…
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SOP for Gel Deaeration Unit Operation and Maintenance of Gel Deaeration Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel deaeration unit to ensure proper removal of air bubbles from gel formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…