Author: Auditor

SOP for Pharmacovigilance International Conference on Harmonization (ICH) Guidelines Compliance

SOP for Pharmacovigilance International Conference on Harmonization (ICH) Guidelines Compliance Guidelines for Pharmacovigilance ICH Guidelines Compliance 1) Purpose The purpose of this SOP is to ensure compliance with International Conference on Harmonization (ICH) guidelines related to pharmacovigilance activities, including safety reporting, risk management, and regulatory submissions. 2) Scope This SOP applies to personnel involved in…

Pharmacovigilance

Powder & Granules: SOP for Tap Density Testing in Granules

SOP for Tap Density Testing in Granules Standard Operating Procedure for Tap Density Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for determining the tap 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 Raw Material Sampling and Testing

SOP for Raw Material Sampling and Testing Standard Operating Procedure for Sampling and Testing Raw Materials 1) Purpose The purpose of this SOP is to establish a procedure for the sampling and testing of raw materials to ensure they meet specified quality standards before use in manufacturing. 2) Scope This SOP applies to all raw…

Rectal Dosage Forms

SOP for Eye Drop Bottle Capping Machine

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

Ocular (Eye) Dosage Forms

SOP for Tablet Crushing Machine

SOP for Tablet Crushing Machine Operation and Maintenance of Tablet Crushing Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet crushing machine to ensure effective crushing of tablets during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…

Vaginal Dosage Forms

SOP for Annual Product Review in MDI Production

SOP for Annual Product Review in MDI Production Annual Product Review Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for conducting annual product reviews (APRs) in metered-dose inhaler (MDI) production to evaluate product quality, process performance, and compliance with regulatory requirements. 2) Scope This SOP applies to all…

Metered-Dose Inhaler

SOP for Tap Density Testing in Powders

SOP for Tap Density Testing in Powders Standard Operating Procedure for Tap Density Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for determining the tap 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

SOP for Ampoule Filling Machine

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

Ocular (Eye) Dosage Forms

SOP for Suppository Transfer Chute

SOP for Suppository Transfer Chute Operation and Maintenance of Suppository Transfer Chute 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository transfer chute to ensure safe and efficient transfer of suppositories during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the…

Vaginal Dosage Forms

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