Richard A. Lewis

Richard A. Lewis is statistics lead, GMS TEC Shared Services, at GlaxoSmithKline.

Articles

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

James D. Colandene;Douglas P. Nesta;Kashappa Goud Desai;Richard A. Lewis

June 2nd 2017

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

Latest Updated Articles

Published: October 11th 2024 | Updated: October 18th 2024

Buy, Sell, Hold: Cell and Gene Therapy - Part 1

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

Published: September 10th 2024 | Updated: September 18th 2024

CPHI Milan Announces 2024 CPHI Pharma Award Finalists

Published: October 28th 2024 | Updated: November 22nd 2024

Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development

Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com

Published: November 6th 2024 | Updated: November 22nd 2024

Automate Aseptic Filling: Closing the System at Full Modularity

Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com

Published: November 5th 2024 | Updated: November 22nd 2024

Untethered Data: Unifying and Contextualizing Drug Discovery Data

Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com

Published: November 8th 2024 | Updated: November 22nd 2024

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

About Us

Advertise

Editorial Info

Editorial Advisory Board

Do Not Sell My Personal Information

Terms and Conditions

Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777