Process Validation

Getting More Scientific About Cleaning Validation

December 01, 2020

The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms

October 16, 2020

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

July 07, 2020

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

June 30, 2020

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Ensuring Smooth Tech Transfer of Bioprocess Operations

April 01, 2020

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Mapping a Route for Cell and Gene Therapy Process Development

January 01, 2020

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Science Focus Fuels Successful Process Development for Startups

April 01, 2019

Getting the science right helps biopharma startups overcome development and commercialization challenges.

Process Validation Sets the Stage for Ongoing Manufacturing Quality

March 01, 2019

A properly designed validation program will detect variation and ensure control based on process risk.

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

September 01, 2018

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.

Continued Process Verification and the Drive to Digitize the Process Validation Lifecycle

July 26, 2018

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.