Tag: kneat validation

SOP Template: Deviation Handling During Product Transit

SOP Template: Deviation Handling During Product Transit SOP Template: Deviation Handling During Product Transit Transporting pharmaceutical products under controlled conditions is essential. This entails meticulous planning, risk assessment, and validation to comply with regulatory standards. The aim of this article…

Label Stock Qualification: Adhesive Strength, Print Durability

Label Stock Qualification: Adhesive Strength, Print Durability Label Stock Qualification: Adhesive Strength, Print Durability In the pharmaceutical industry, ensuring the integrity and compliance of packaging systems is paramount. One critical aspect of this process is the qualification of label stock,…

Velocity and Uniformity Testing in Laminar Airflow Units

Velocity and Uniformity Testing in Laminar Airflow Units Velocity and Uniformity Testing in Laminar Airflow Units This article provides a detailed, step-by-step validation tutorial on velocity and uniformity testing in laminar airflow units, focusing on kneat validation, and ensuring compliance…

Handling Raw Data for Validation in Audit-Ready Format

Handling Raw Data for Validation in Audit-Ready Format Handling Raw Data for Validation in Audit-Ready Format The validation of pharmaceutical processes is both a regulatory requirement and a crucial aspect of maintaining product quality. One of the key areas within…

WHO TRS, PIC/S and ICH References for VMP Creation

WHO TRS, PIC/S and ICH References for VMP Creation WHO TRS, PIC/S and ICH References for VMP Creation The development of a Validation Master Plan (VMP) is a crucial step in ensuring that pharmaceutical processes and systems comply with regulatory…

Spreadsheet Inventory and Risk Assessment Template

Spreadsheet Inventory and Risk Assessment Template Spreadsheet Inventory and Risk Assessment Template This article provides a comprehensive step-by-step tutorial on implementing a spreadsheet inventory and risk assessment within the context of kneat validation. This approach aligns with regulatory frameworks, including…

Deviations During IQ/OQ/PQ: How to Handle Them

Deviations During IQ/OQ/PQ: How to Handle Them Deviations During IQ/OQ/PQ: How to Handle Them The validation lifecycle in the pharmaceutical industry is a critical component ensuring that products meet specified requirements for quality and compliance. During installation qualification (IQ), operational…

Difference Between Protocol and Report in Process Validation

Difference Between Protocol and Report in Process Validation Difference Between Protocol and Report in Process Validation In the world of pharmaceutical manufacturing, ensuring quality and compliance is paramount. One of the critical components of this endeavor is understanding the essential…