Quality Risk Management: Looking North

Kevin North is a busy guy. As President and CEO of software and solutions provider Dyadem, he's no doubt got a lot on his plate, and has overseen the growth of a company whose products have been winning awards and winning converts among pharma Quality professionals. North was also a finalist this year for Ernst & Young's Entrepreneur of the Year.

All of which meant that I wasn't surprised when my list of questions to North about Dyadem and its pharma initiatives went unanswered for a few months. He did, however, promise that he would answer them when he could. True to his word, North followed up with me this week. Here is our conversation on Quality Risk Management, and we'll also be following up with Dyadem in the future about another of its core competencies, FMEA.

If there's one thing that strikes me about his replies, it's that the solutions that Dyadem offers are beyond what many manufacturers have even considered as a means of improving QRM and complementing Quality by Design programs. He says:

"Most FDA-regulated companies will tell you that they believe in the FDA’s QbD initiative, but they have a hard time putting it into practice efficiently, especially since many haven’t updated their risk management procedures since the advent of spreadsheet software. Many companies use Excel spreadsheets or customized software for each department and then spend hours trying to cut and paste information together to represent quality for the whole company. Companies that take Quality Risk Management seriously need software that was designed for risk management, not accounting."

Can PCMO and PQLI Work in Harmony for Paradigm Change?

PDA has stepped up its efforts to get its training and technical reports more in tune with ICH and a more risk- and science-based industry. These efforts have been underway, says PDA's Rich Levy, but the Paradigm Change in Manufacturing Operations initiative puts them into focus.

PDA has drafted a dossier around four key themes: Life Cycle Approach, Quality Systems, Process Management, and Quality Risk Management, and will use this dossier as the umbrella under which ongoing efforts will be undertaken.

In this article from my recent discussion with Levy, he goes out of his way to emphasize that PCMO is intended to complement, not counter, PQLI efforts already underway at ISPE.

--Paul Thomas

Risk Management Strategies for Extractables and Leachables

FDA's Ingrid Markovic has just published in American Pharmaceutical Review on risk management for extractables and leachables. Here's a link (subscription required), and here is the abstract:

Extractables and leachables (E&L) are chemical entities, which can be released into intermediate material or final therapeutic biologic protein product at various times during upstream and/ or downstream manufacturing steps, packaging operations and/or storage. These substances may pose a safety risk to the patient by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. They may also alter product physico-chemical properties via direct interaction with the active pharmaceutical ingredient or, indirectly, by interacting with the excipients in product vehicle, thereby adversely affecting the product quality. Current paper will address a risk-based approach to conceptualizing, evaluating and executing identification and characterization of E&L along with regulatory considerations regarding the impact of these impurities on product quality, patient safety and clinical efficacy. Selected case studies are presented and discussed.

Quality Risk Management in Jersey

Roche and Dyadem have put together a program on Quality Risk Management for the end of this month in Princeton, N.J. Dyadem's offerings are well positioned for the QbD movement . . . should be an interesting program.

--Paul Thomas