Author: Auditor

SOP for Pharmacovigilance Post-Authorization Safety Studies (PASS)

SOP for Pharmacovigilance Post-Authorization Safety Studies (PASS) Guidelines for Pharmacovigilance Post-Authorization Safety Studies (PASS) 1) Purpose The purpose of this SOP is to establish procedures for the planning, conduct, and reporting of Post-Authorization Safety Studies (PASS) in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for the design, execution, and oversight of PASS…

Pharmacovigilance

SOP for Storage Conditions of Powders

SOP for Storage Conditions of Powders Standard Operating Procedure for Storage Conditions of Powders 1) Purpose The purpose of this SOP is to define the standard storage conditions for powders 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

SOP for Handling of Out-of-Specification Results

SOP for Handling of Out-of-Specification Results Standard Operating Procedure for Handling of Out-of-Specification Results 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the handling and investigation of out-of-specification (OOS) results in pharmaceutical manufacturing to ensure product quality and compliance with regulatory requirements. 2) Scope This SOP applies…

Injectables

Vaginal Dosage Forms: SOP for Tablet Sorter

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

Vaginal Dosage Forms

SOP for Handling and Disposal of Waste in MDI Production

SOP for Handling and Disposal of Waste in MDI Production Waste Handling and Disposal Procedures for MDI Production 1) Purpose The purpose of this SOP is to outline the procedures for the proper handling and disposal of waste generated during the production of metered-dose inhalers (MDIs) to ensure environmental protection, safety, and compliance with regulatory…

Metered-Dose Inhaler

SOP for Calibration of Equipment Used for Granules

SOP for Calibration of Equipment Used for Granules Standard Operating Procedure for Calibration of Equipment Used for Granules 1) Purpose The purpose of this SOP is to provide a standardized procedure for the calibration of equipment used in the manufacturing of granules in the pharmaceutical industry to ensure accurate and reliable performance. 2) Scope This…

Powder & Granules

SOP for Suppository Printing Machine

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

Vaginal Dosage Forms

SOP for Pharmacovigilance Development Safety Update Reports (DSUR)

SOP for Pharmacovigilance Development Safety Update Reports (DSUR) Guidelines for Pharmacovigilance Development Safety Update Reports (DSUR) 1) Purpose The purpose of this SOP is to outline procedures for the preparation, review, and submission of Development Safety Update Reports (DSURs) in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for the preparation, review, and…

Pharmacovigilance

SOP for Gel Filling and Sealing Machine

SOP for Gel Filling and Sealing Machine Operation and Maintenance of Gel Filling and Sealing Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel filling and sealing machine to ensure efficient and accurate filling and sealing of gel formulations. 2) Scope This SOP applies to…

Vaginal Dosage Forms

Powder & Granules: SOP for Calibration of Equipment Used for Granules

Powder & Granules