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NSF-IPEC 363 GMP Standard Will Provide Risk-Based Approach for Auditing and Certifying Excipient Manufacturers

Aug 20th, 2013

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NSF International is working with the International Pharmaceutical Excipients Council (IPEC) and FDA to turn the IPEC excipient GMPs into a risk-based, certifiable standard with global applicability by the end of 2013, as recognition of the importance of excipient control continues to grow.

ANSI NSF-IPEC 363 will provide a stand-alone, quality system-based GMP standard that industry and regulatory agencies can use in evaluating, auditing, and certifying excipient manufacturing and quality.  It is intended to make excipient manufacturing risk more transparent and drive better knowledge management.

NSF is one of the few organizations accredited by the American National Standards Institute (ANSI) to develop “national consensus standards” – standards that can be adopted and used by US government agencies such as FDA when the agency has not developed its own standard.  Participation of industry suppliers and users, FDA and academia in developing the excipient GMP standard – along with a public comment process – means that the standard will be fully vetted prior to its adoption.

NSF International is a not-for-profit global independent public health organization that writes standards, tests and certifies products, and does training and auditing for the food, water and health sciences industries.

NSF has announced that it will be acquiring International Pharmaceutical Excipient Auditing (IPEA) from IPEC with the goal of strengthening IPEA’s reach and capabilities in third-party auditing and certification.  The acquisition is scheduled to be completed by the end of the year.

IPEA will become part of NSF’s recently-established Health Sciences Pharma/Biotech Division, led by Neil Wilkinson.  During his career at AstraZeneza, Wilkinson played a significant role through ICH and EFPIA in international quality policy development and harmonization efforts.

In 2010, NSF acquired David Begg Associates (DBA), where Wilkinson was a partner with responsibility for its growing US presence.  Established in 1986, DBA has focused on developing expertise in pharmaceutical quality management, regulatory compliance, and training – in particular, training programs for quality professionals globally and certification preparation for the qualified person (QP) in Europe.

NSF health sciences reach further expanded in 2012 with the acquisition of Becker and Associates, a Washington, D.C.-based consulting firm with strong medical device expertise.  Ron Johnson, a former FDA field and center topsider, is continuing to lead the Becker group for NSF.  Johnson’s career at FDA included serving as director of the agency’s Pacific Region, compliance office director at the Center for Devices and Radiological Health (CDRH), and chair of various FDA field committees.

363 Matches Control Expectations With Risk

The shift in the pharmaceutical regulatory paradigm toward the QbD, risk management, and quality system principles embedded in ICH Q8-10 is bringing excipient control more squarely into the regulatory fold.  A central concern for the international pharmaceutical community is how to make this transition happen in a way that is as manageable and efficient as possible for suppliers, users, and regulators.

The 363 consensus standard will provide a consistent yardstick to measure the performance of excipient manufacturers.  In turn, it will provide a framework for excipient quality control and risk management that is consistent with the ICH Q8-10 principles.

The content and significance of the new NSF-IPEC 363 standard drew significant attention at an April 30-May 1 “ExcipientFest” conference in Baltimore, Maryland, sponsored by IPEC.

A breakout session was held on the standard at which NSF Executive VP Lori Bestervelt provided an overview of its development and objectives.

Citing excipient provisions in the FDA Safety and Innovation Act (FDASIA) (IPQ, May 11, 2013) and the EU Falsified Medicines Directive (FMD) (IPQ, May 31, 2011), Bestervelt explained that the 363 standard will provide a tool “to help us navigate in the new and changing landscape of rules and regulations.”

She noted that a key component of the new standard is its incorporation of a risk assessment process that can be applied irrespective of the particular excipient and that will keep the standard from becoming too prescriptive.

In a plenary session at the ExcipientFest meeting, CDER Office of Drug Security, Integrity and Recalls (ODSIR) Associate Director for Risk Science, Intelligence and Prioritization Steve Wolfgang – a member of the NSF-IPEC 363 drafting committee – provided a “regulator’s perspective” on the standard, echoing Bestervelt on the importance of its risk assessment approach (see box at the end of the story for Wolfgang’s remarks on the 363 standard).

The use of QRM, he said, allows the tailoring of individual approaches “to prevent against contamination and mix-ups and to also ensure that end-user requirements are consistently met with a high level of consideration of pharmaceutical quality and patient safety.”

Wolfgang commented that, although the standard will not cover “every single aspect” of excipient quality, it will provide a “baseline” that will help a pharma company determine “whether or not an excipient should even be thought about being used.”

At a “Pharmaceutical Supply Chain Workshop” co-sponsored by PDA and FDA in Bethesda, MD in early June, Huber Engineered Materials Global Quality Director Dale Carter – immediate past chair of IPEC and also a member of the 363 drafting committee – emphasized that the use of risk assessment in the standard “has changed the paradigm” in excipient quality assessment.

“It is forcing the excipient companies to understand why they do things and to prove it to an auditor,” he explained. “So now you defend why you are wearing a hairnet, not just ‘we got one on, don’t worry about it.’  Instead of just putting on the hairnet and walking in, they understand the purpose of the hairnet – what they are trying to control.”

If companies and individuals understand the risks and why controls were put in place to mitigate the risks, Carter pointed out, then when older employees retire and the younger people take their place, “they understand how to keep these things current because they understand the risk.  They are not just trying to copy something.”

The standard requires “a lot more than a check in a box,” Carter stressed.  “It is a lot of justification for what they are doing, why they are doing it, and why is it acceptable.”

[The story continues for subscribers beginning on page 2, and includes insights by several other prominent experts on the development and significance of NSF-IPEC 363.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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