Tag: process validation in pharma

Periodic Revalidation: Frequency, Requirements, and Templates

Periodic Revalidation: Frequency, Requirements, and Templates Periodic Revalidation: Frequency, Requirements, and Templates Periodic revalidation is an essential aspect of the lifecycle of process validation in the pharmaceutical industry. This article offers a comprehensive, step-by-step tutorial on the validation lifecycle, ensuring…

Change Control for Document Revisions in Validation Projects

Change Control for Document Revisions in Validation Projects Change Control for Document Revisions in Validation Projects Effective change control is a critical component of validation projects in the pharmaceutical industry, ensuring compliance with regulations and maintaining the integrity of validated…

Creating a Risk Priority Number (RPN) Matrix Template

Creating a Risk Priority Number (RPN) Matrix Template Creating a Risk Priority Number (RPN) Matrix Template The validation lifecycle in the pharmaceutical industry is a complex and detailed process governed by stringent regulatory requirements. Understanding and implementing a Risk Priority…

Fault Tree Analysis (FTA) Explained for Validation Teams

Fault Tree Analysis (FTA) Explained for Validation Teams Fault Tree Analysis (FTA) Explained for Validation Teams Fault Tree Analysis (FTA) is a critical risk management tool utilized in the process validation lifecycle within the pharmaceutical industry. This step-by-step tutorial provides…

VMP Integration with Vendor Qualification and Tech Transfer

VMP Integration with Vendor Qualification and Tech Transfer VMP Integration with Vendor Qualification and Tech Transfer In the pharmaceutical industry, the principles of process validation are essential for ensuring that products meet their predetermined specifications and quality attributes. A comprehensive…

Acceptance Criteria for Accuracy, Precision, and Linearity in Pharma

Acceptance Criteria for Accuracy, Precision, and Linearity in Pharma Acceptance Criteria for Accuracy, Precision, and Linearity in Pharma In the pharmaceutical industry, validation of processes used in the production of drugs is crucial for ensuring their safety, efficacy, and quality.…

Precision in Method Validation: Repeatability vs Reproducibility Explained

Precision in Method Validation: Repeatability vs Reproducibility Explained Precision in Method Validation: Repeatability vs Reproducibility Explained In the pharmaceutical industry, ensuring the reliability and accuracy of methods used in both research and production is paramount. This comprehensive guide will introduce…

Cybersecurity and CSV: Protecting Cloud-Based Pharma Data

Cybersecurity and CSV: Protecting Cloud-Based Pharma Data Cybersecurity and CSV: Protecting Cloud-Based Pharma Data Step 1: User Requirement Specification (URS) and Risk Assessment Establishing a foundation for robust process validation in pharma begins with the creation of a comprehensive User…

HVAC Zoning and Pressure Cascade Validation in Controlled Environments

HVAC Zoning and Pressure Cascade Validation in Controlled Environments HVAC Zoning and Pressure Cascade Validation in Controlled Environments In the pharmaceutical industry, ensuring environmental integrity through proper HVAC (Heating, Ventilation, and Air Conditioning) zoning and pressure cascade validation is pivotal…

How to Perform Airflow Visualization (Smoke Study) for Cleanrooms

How to Perform Airflow Visualization (Smoke Study) for Cleanrooms How to Perform Airflow Visualization (Smoke Study) for Cleanrooms Airflow visualization, often referred to as a smoke study, is an essential component of process validation in the pharmaceutical industry, particularly in…