Author: Auditor

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

SOP for Training Personnel in MDI Production

SOP for Training Personnel in MDI Production Personnel Training Procedures for MDI Production 1) Purpose The purpose of this SOP is to establish procedures for the training of personnel involved in the production of metered-dose inhalers (MDIs) to ensure competency, adherence to procedures, and compliance with regulatory requirements. 2) Scope This SOP applies to all…

Metered-Dose Inhaler

Injectables: SOP for Handling and Storage of Controlled Substances

SOP for Handling and Storage of Controlled Substances Standard Operating Procedure for Handling and Storage of Controlled Substances 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the secure handling, storage, and disposal of controlled substances within the pharmaceutical manufacturing facility to prevent unauthorized access, diversion, or misuse. 2)…

Injectables

SOP for Ring Inspection Unit

SOP for Ring Inspection Unit Operation and Maintenance of Ring Inspection Unit 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring inspection unit to ensure thorough inspection and quality control of rings. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and…

Vaginal Dosage Forms

SOP for Handling and Disposal of Waste in Powders Production

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

Powder & Granules

SOP for Pharmacovigilance Risk Communication Plan

SOP for Pharmacovigilance Risk Communication Plan Guidelines for Pharmacovigilance Risk Communication Plan 1) Purpose The purpose of this SOP is to establish procedures for identifying, evaluating, and communicating risks associated with medicinal products in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for developing, implementing, and monitoring risk communication strategies within the organization….

Pharmacovigilance

SOP for Gel Cooling System

SOP for Gel Cooling System Operation and Maintenance of Gel Cooling System 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel cooling system to ensure proper cooling of gel formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

Vaginal Dosage Forms

SOP for Storage Conditions of Granules

SOP for Storage Conditions of Granules Standard Operating Procedure for Storage Conditions of Granules 1) Purpose The purpose of this SOP is to define the standard storage conditions for granules in the pharmaceutical industry to maintain their stability and quality throughout their shelf-life. 2) Scope This SOP applies to all personnel involved in the storage…

Powder & Granules