Author: Auditor

SOP for Training Personnel in Granules Production

SOP for Training Personnel in Granules Production Standard Operating Procedure for Training Personnel in Granules Production 1) Purpose The purpose of this SOP is to establish procedures for the training of personnel involved in granules production within the pharmaceutical industry to ensure competency, adherence to procedures, and compliance with regulatory requirements. 2) Scope This SOP…

Powder & Granules

SOP for Pharmacovigilance Case Triage

SOP for Pharmacovigilance Case Triage Guidelines for Pharmacovigilance Case Triage 1) Purpose The purpose of this SOP is to establish procedures for the initial assessment and classification of incoming adverse event reports in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for triaging adverse event reports within the organization. 3) Responsibilities The Pharmacovigilance…

Pharmacovigilance

SOP for Suppository Labeling Machine

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

Vaginal Dosage Forms

SOP for Ring Packaging Sealer

SOP for Ring Packaging Sealer Operation and Maintenance of Ring Packaging Sealer 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring packaging sealer to ensure effective sealing of ring packaging. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

Vaginal Dosage Forms

SOP for Training Personnel in Powders Production

SOP for Training Personnel in Powders Production Standard Operating Procedure for Training Personnel in Powders Production 1) Purpose The purpose of this SOP is to establish procedures for the training of personnel involved in powders production within the pharmaceutical industry to ensure competency, adherence to procedures, and compliance with regulatory requirements. 2) Scope This SOP…

Powder & Granules

SOP for Maintaining Sterility in MDI Production

SOP for Maintaining Sterility in MDI Production Sterility Maintenance Procedures for MDI Production 1) Purpose The purpose of this SOP is to establish procedures for maintaining sterility during the production of metered-dose inhalers (MDIs) to prevent microbial contamination and ensure product safety and efficacy. 2) Scope This SOP applies to all personnel involved in sterile…

Metered-Dose Inhaler

SOP for Gel Storage Tank

SOP for Gel Storage Tank Operation and Maintenance of Gel Storage Tank 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel storage tank to ensure proper storage and preservation of gel formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and…

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Vaginal Dosage Forms

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