Voice of Regulators

Published on: 
BioPharm International, BioPharm International, November 2022, Volume 35, Issue 11
Pages: 3

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.

As a CEO in a well-regulated industry, it is a straightforward path to respect the utility of authority, guidance, standards, laws, and penalties. Complex systems function more crisply when rules and expectations are clear to all, and all are equally clear on what is required of them. It is with great pride I outline our increased coverage of this landscape now, but also extending well into 2023.

A strong series of articles called “FDA Voices” will have a bi-monthly cadence next year. This series will cover core topics FDA staff are prioritizing. This series provides unique input from the front ranks of FDA and is eye catching content and analysis. We plan to start the series with a bonus early installment in our December issue around “distributed and point of care manufacturing” from FDA’s perspective.

Well underway already has been another new series of articles surrounding “Pharmaceutical Quality Systems and Post-Approval Changes”. This series of papers, from One-Voice-of-Quality for Post-Approval Changes (1VQ for PAC), sponsored by the Chief Quality Officers of the largest pharma companies, maintains that manufacturers should be allowed to manage some post-approval changes themselves in their pharmaceutical quality system (PQS) only, and without prior approval when they can demonstrate to regulators product and process knowledge as well as an effective PQS. A perspective from a very different angle and lens.

Most unusually, I’d like to take this opportunity to alert every company to our exclusive Quality Management Maturity (QMM) series. Yet another distinct voice and perspective, this time from Somnath Mishra, president, Shabas Solutions LLC. Somnath and team ran one of two FDA QMM pilot programs. Shabas ran the overseas pilot. In December 2022, the first article will introduce QMM from a practitioner’s standpoint, and educate the industry about its many benefits, and affirm that quality maturity models are nothing new per se. This article will set the tone for subsequent articles where elaboration on practical guidance on QMM adoption at sites, and then on selected topics related to QMM implementation/adoption. Without question this invaluable series will encourage industry to begin plans on how to achieve great grades when it comes to QMM.


About the author

Mike Hennessy Jr. is the President and CEO of MJH Life Sciences.

Article details

BioPharm International
Vol. 35, No. 11
November 2022
Page: 3


When referring to this article, please cite it as M. Hennessy, “Voice of Regulators,” BioPharm International 35 (11) 36–40 (2022).