IPEC leaders are touting the multilayered benefits to excipient manufacturers and their pharma customers of establishing and documenting the more formal risk assessment processes called for in the recent industry and regulator excipient GMP standards.
Among those experts who have been endorsing the value of a more full deployment of the risk assessment processes provided in the standards is Dow Pharma and Food Solutions Global Business Quality Leader Ann Van Meter, who chairs IPEC-Americas’ GMP Committee. Van Meter retired from Dow in mid-2016 after a lengthy career with the company.
“We are going to be hearing a lot more about risk assessment over the coming years,” she stressed at the 2016 IPEC-Americas/ExcipientFest conference – reflective of not only the NSF/IPEC/ANSI 363 and EXCiPACT excipient GMP standards, but the new ISO 2015 standard, which also “built in quite a bit of risk assessment techniques and requirements.”
She noted that a draft of an in-depth risk assessment guide is now being developed by IPEC-America’s Regulatory Affairs Committee under the leadership of Lubrizol Life Sciences Global Regulatory Affairs Manager Meera Raghuram and that some of the insights and examples from the working draft had been incorporated in her presentation.
Van Meter emphasized that “the process of performing those risk assessments and really looking at your processes – your work processes, your procedures – is where the real benefit of moving through the risk assessments to full compliance with the [IPEC excipient GMP] guide is really going to add the value for you.”
In her presentation at the conference, Van Meter sought to “answer the question” of where the additional benefit of implementing the EXCIPACT and ANSI standards lay. She highlighted the benefits that ensue for quality personnel, for manufacturing/production leadership, at the business level, and on the shop floor.
Industry requirements in the pharma quality environment are converging on risk assessment, she stressed, and “for me, risk assessment is all about the power of ‘why.’” The potency, she affirmed, lies in “going far beyond the check-the-box mentality to look at why you are doing what you are doing” – a process that impacts the GMP culture at all levels of the organization.