Quality Systems

Articles

Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.

“Waive Vaccine Patents” is Projected onto Hotel Hosting UK’s Annual Conservative Conference

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.

European Pharmacopoeia Updates: EDQM Tackles Nitrosamine Impurities

Jaap Venema, PhD, is Executive Vice President and Chief Science at US Pharmacopeia (USP).

Jennifer Devine, JD, is Senior Vice President, Documentary Standards and Compendial Policy at US Pharmacopeia (USP).

Public health challenges have highlighted the need for agility in maintaining the quality of medicines. 

Public Trust in Medicine Quality as Public Health Challenges Emerge

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

FDA Moves to Advance Innovative Excipients

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

The Basics of Aseptic Processing

Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.

Antiviral Oral Medicine Emerges as Potential COVID-19 Treatment and Companies Make Strategic Alliance

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

FDA to Rely on Real World Data and Evidence for Future Research and Market Approvals

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax. 

CHMP Performs Accelerated Assessment of Booster Dose of Spikevax

EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.

Regulatory Oversight and Compliance