Author: Auditor

SOP for Pharmacovigilance Risk Management Committee (RMC)

SOP for Pharmacovigilance Risk Management Committee (RMC) Guidelines for Pharmacovigilance Risk Management Committee (RMC) 1) Purpose The purpose of this SOP is to define the roles, responsibilities, and procedures for the Pharmacovigilance Risk Management Committee (RMC) in evaluating and managing risks associated with medicinal products. 2) Scope This SOP applies to members of the Pharmacovigilance…

Pharmacovigilance

SOP for Cream Mixing Vessel

SOP for Cream Mixing Vessel Operation and Maintenance of Cream Mixing Vessel 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream mixing vessel to ensure consistent mixing of cream formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

Vaginal Dosage Forms

SOP for Raw Material Inspection for Powders

SOP for Raw Material Inspection for Powders Standard Operating Procedure for Raw Material Inspection for Powders 1) Purpose The purpose of this SOP is to define the procedures for the inspection and testing of raw materials used in powders production within the pharmaceutical industry to ensure quality, safety, and compliance with specifications. 2) Scope This…

Powder & Granules

SOP for Tablet Counting Machine

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

Vaginal Dosage Forms

Injectables: SOP for Sampling Procedures for Raw Materials and Finished Products

SOP for Sampling Procedures for Raw Materials and Finished Products Standard Operating Procedure for Sampling Procedures for Raw Materials and Finished Products 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the sampling of raw materials and finished products within the pharmaceutical manufacturing facility to ensure representative samples for…

Injectables

SOP for Preventing Contamination in MDI Production

SOP for Preventing Contamination in MDI Production Contamination Prevention Procedures for MDI Production 1) Purpose The purpose of this SOP is to establish procedures for preventing contamination during the production of metered-dose inhalers (MDIs) to ensure product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in MDI…

Metered-Dose Inhaler

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