Author: Auditor

SOP for Pharmacovigilance Signal Detection Activities

SOP for Pharmacovigilance Signal Detection Activities Guidelines for Pharmacovigilance Signal Detection Activities 1) Purpose The purpose of this SOP is to establish procedures for the proactive detection, assessment, and management of signals related to adverse events or potential risks associated with medicinal products. 2) Scope This SOP applies to pharmacovigilance personnel responsible for signal detection…

Pharmacovigilance

Injectables: SOP for Document Control and Management

SOP for Document Control and Management Standard Operating Procedure for Document Control and Management 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a framework for the creation, review, approval, distribution, and maintenance of documents within the pharmaceutical manufacturing facility to ensure accuracy, traceability, and compliance with regulatory requirements. 2) Scope…

Injectables

SOP for Documentation in Granules Production

SOP for Documentation in Granules Production Standard Operating Procedure for Documentation in Granules Production 1) Purpose The purpose of this SOP is to outline the procedures for documenting various activities and processes involved in granules production in the pharmaceutical industry to ensure traceability, accountability, and regulatory compliance. 2) Scope This SOP applies to all personnel…

Powder & Granules

SOP for Cream Emulsion Tank

SOP for Cream Emulsion Tank Operation and Maintenance of Cream Emulsion Tank 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream emulsion tank to ensure proper emulsification of cream formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

Vaginal Dosage Forms

SOP for Documentation in Powders Production

SOP for Documentation in Powders Production Standard Operating Procedure for Documentation in Powders Production 1) Purpose The purpose of this SOP is to outline the procedures for documenting various activities and processes involved in powders production in the pharmaceutical industry to ensure traceability, accountability, and regulatory compliance. 2) Scope This SOP applies to all personnel…

Powder & Granules

SOP for Raw Material Inspection for MDIs

SOP for Raw Material Inspection for MDIs Raw Material Inspection Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the manufacturing of metered-dose inhalers (MDIs) to ensure quality, safety, and compliance with specifications. 2) Scope This SOP applies to all…

Metered-Dose Inhaler

SOP for Tablet Sorting Machine

SOP for Tablet Sorting Machine Operation and Maintenance of Tablet Sorting Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet sorting machine to ensure accurate sorting and inspection of tablets. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

Vaginal Dosage Forms

SOP for Pharmacovigilance Aggregate Report Submission

SOP for Pharmacovigilance Aggregate Report Submission Guidelines for Pharmacovigilance Aggregate Report Submission 1) Purpose The purpose of this SOP is to outline procedures for the preparation, review, and submission of pharmacovigilance aggregate reports to regulatory authorities. 2) Scope This SOP applies to pharmacovigilance personnel responsible for compiling, verifying, and submitting aggregate reports within the organization….

Pharmacovigilance

SOP for Handling and Disposal of Waste in Granules Production

SOP for Handling and Disposal of Waste in Granules Production Standard Operating Procedure for Handling and Disposal of Waste in Granules Production 1) Purpose The purpose of this SOP is to establish guidelines for the proper handling, segregation, and disposal of waste generated during granules production in the pharmaceutical industry to ensure environmental safety and…

Powder & Granules

SOP for Suppository Capping Machine

SOP for Suppository Capping Machine Operation and Maintenance of Suppository Capping Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository capping machine to ensure proper sealing and packaging of suppositories. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

Vaginal Dosage Forms