Author: Auditor

SOP for IT Systems Validation and Data Integrity

SOP for IT Systems Validation and Data Integrity Standard Operating Procedure for IT Systems Validation and Data Integrity 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the validation and maintenance of information technology (IT) systems used in pharmaceutical manufacturing to ensure data integrity, system reliability, and compliance with…

Injectables

Powder & Granules: SOP for Flowability Testing in Powders

SOP for Flowability Testing in Powders Standard Operating Procedure for Flowability Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for assessing the flowability of powder formulations in the pharmaceutical industry to ensure proper handling and processing. 2) Scope This SOP applies to all personnel involved in flowability testing…

Powder & Granules

SOP for Gel Manufacturing Vessel

SOP for Gel Manufacturing Vessel Operation and Maintenance of Gel Manufacturing Vessel 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the gel manufacturing vessel to ensure efficient production of gel formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of…

Vaginal Dosage Forms

SOP for Batch Coding Machine

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

Ocular (Eye) Dosage Forms

SOP for Cleaning Validation in MDI Production

SOP for Cleaning Validation in MDI Production Cleaning Validation Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for cleaning validation in metered-dose inhaler (MDI) production to ensure equipment cleanliness and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in cleaning validation activities within…

Metered-Dose Inhaler

SOP for Cream Homogenization Tank

SOP for Cream Homogenization Tank Operation and Maintenance of Cream Homogenization Tank 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream homogenization tank to ensure proper homogenization of cream during the manufacturing process. 2) Scope This SOP applies to all personnel involved in the operation, cleaning,…

Vaginal Dosage Forms

SOP for Labeling Machine for Eye Drops

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

Ocular (Eye) Dosage Forms

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