Author: Auditor

SOP for Requalification of Equipment and Systems

SOP for Requalification of Equipment and Systems Standard Operating Procedure for Requalification of Equipment and Systems 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the requalification of equipment, utilities, facilities, and systems within the pharmaceutical manufacturing facility to ensure continued compliance with regulatory requirements and consistent product quality….

Injectables

SOP for Pharmacovigilance Medical Dictionary for Regulatory Activities (MedDRA) Coding

SOP for Pharmacovigilance Medical Dictionary for Regulatory Activities (MedDRA) Coding Guidelines for Pharmacovigilance MedDRA Coding 1) Purpose The purpose of this SOP is to establish standardized procedures for the coding of adverse events and medical conditions using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in pharmacovigilance. 2) Scope This SOP applies to personnel responsible…

Pharmacovigilance

SOP for Bulk Density Testing in Granules

SOP for Bulk Density Testing in Granules Standard Operating Procedure for Bulk Density Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for determining the bulk density of granule formulations in the pharmaceutical industry to ensure consistency and quality. 2) Scope This SOP applies to all personnel involved in…

Powder & Granules

SOP for Syringe Filling Machine

SOP for Syringe Filling Machine Standard Operating Procedure for Syringe Filling Machine Operation 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Syringe Filling Machine used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Syringe Filling Machine used…

Ocular (Eye) Dosage Forms

SOP for Ring Extruder

SOP for Ring Extruder Operation and Maintenance of Ring Extruder 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the ring extruder to ensure proper extrusion of rings during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

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Vaginal Dosage Forms

SOP for Raw Material Receipt and Storage

SOP for Raw Material Receipt and Storage Standard Operating Procedure for Receiving and Storing Raw Materials 1) Purpose The purpose of this SOP is to establish a procedure for the proper receipt and storage of raw materials to ensure their quality and integrity are maintained. 2) Scope This SOP applies to all raw materials used…

Rectal Dosage Forms

SOP for Batch Record Review in MDI Production

SOP for Batch Record Review in MDI Production Batch Record Review Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for reviewing batch records in metered-dose inhaler (MDI) production to ensure accuracy, completeness, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in batch…

Metered-Dose Inhaler

SOP for Vial Filling Machine

SOP for Vial Filling Machine Standard Operating Procedure for Vial Filling Machine Operation 1) Purpose The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Vial Filling Machine used in the manufacturing of ocular dosage forms. 2) Scope This SOP applies to the Vial Filling Machine used…

Ocular (Eye) Dosage Forms

SOP for Gel Storage Tank Agitator

SOP for Gel Storage Tank Agitator Operation and Maintenance of Gel Storage Tank Agitator 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel storage tank agitator to ensure proper mixing and storage of gel during the manufacturing process. 2) Scope This SOP applies to all personnel…

Vaginal Dosage Forms

SOP for Bulk Density Testing in Powders

SOP for Bulk Density Testing in Powders Standard Operating Procedure for Bulk Density Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for determining the bulk density of powder formulations in the pharmaceutical industry to ensure consistency and quality. 2) Scope This SOP applies to all personnel involved in…

Powder & Granules