Author: Auditor

SOP for Pharmacovigilance Inspection Management

SOP for Pharmacovigilance Inspection Management Guidelines for Pharmacovigilance Inspection Management 1) Purpose The purpose of this SOP is to outline procedures for managing pharmacovigilance inspections conducted by regulatory authorities to ensure compliance with applicable regulations and guidelines. 2) Scope This SOP applies to the Pharmacovigilance (PV) department and relevant stakeholders involved in preparing for and…

Pharmacovigilance

SOP for Final Product Inspection for MDIs

SOP for Final Product Inspection for MDIs Final Product Inspection Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for conducting final product inspection of metered-dose inhalers (MDIs) to ensure compliance with quality standards, specifications, and regulatory requirements before release. 2) Scope This SOP applies to all personnel involved in…

Metered-Dose Inhaler

SOP for Tablet Defoiling Machine

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

Vaginal Dosage Forms

SOP for Maintaining Sterility in Granules Production

SOP for Maintaining Sterility in Granules Production Standard Operating Procedure for Maintaining Sterility in Granules Production 1) Purpose The purpose of this SOP is to establish procedures for maintaining sterility throughout the granules production process in the pharmaceutical industry to prevent contamination and ensure product quality. 2) Scope This SOP applies to all personnel involved…

Powder & Granules

SOP for Suppository Cartoning Machine

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

Vaginal Dosage Forms

SOP for Pharmacovigilance Adjudication Committee

SOP for Pharmacovigilance Adjudication Committee Guidelines for Pharmacovigilance Adjudication Committee 1) Purpose The purpose of this SOP is to define the roles, responsibilities, and procedures for the Pharmacovigilance Adjudication Committee in assessing and adjudicating individual case safety reports (ICSRs) in pharmacovigilance. 2) Scope This SOP applies to members of the Pharmacovigilance Adjudication Committee within the…

Pharmacovigilance

Injectables: SOP for Control of Non-Conforming Materials

SOP for Control of Non-Conforming Materials Standard Operating Procedure for Control of Non-Conforming Materials 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define procedures for identifying, documenting, evaluating, and controlling non-conforming materials within the pharmaceutical manufacturing facility to prevent unintended use or distribution. 2) Scope This SOP applies to all personnel…

Injectables

SOP for In-process Testing for MDIs

SOP for In-process Testing for MDIs In-process Testing Procedures for MDIs 1) Purpose The purpose of this SOP is to establish procedures for conducting in-process testing during the manufacturing of metered-dose inhalers (MDIs) to ensure product quality, identify deviations, and facilitate real-time adjustments. 2) Scope This SOP applies to all personnel involved in in-process testing…

Metered-Dose Inhaler

SOP for Ring Extrusion Die

SOP for Ring Extrusion Die Operation and Maintenance of Ring Extrusion Die 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring extrusion die to ensure accurate and consistent production of rings. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance…

Vaginal Dosage Forms

SOP for Maintaining Sterility in Powders Production

SOP for Maintaining Sterility in Powders Production Standard Operating Procedure for Maintaining Sterility in Powders Production 1) Purpose The purpose of this SOP is to establish procedures for maintaining sterility throughout the powders production process in the pharmaceutical industry to prevent contamination and ensure product quality. 2) Scope This SOP applies to all personnel involved…

Powder & Granules