The New York Attorney General’s sweeping investigation of nutritional supplement manufacturing practices last year sent waves through the supplement and drug manufacturing industries. One solid defense these industries could agree on was ensuring that drug- and supplement-makers fully understood GMP (good manufacturing practices).
But understanding GMP and implementing it are two different stages of key practices that make sure products are consistent and safe for customers. Our industries wouldn’t tolerate weighing scales that couldn’t guarantee that 500 mg of ibuprofen was the same no matter where or how it was measured. The same principle applies to GMP—these practices must be applied consistently. And only a third-party evaluation by a respected auditor can make sure—to the industry, to its customers and to its regulators—that GMP is being consistently followed.
Today, in fact, there is not necessarily a common understanding of GMP regulations. Nor is there a common view of how the FDA inspects pharmaceutical facilities. In many instances, these inspections follow no pattern at all, sometimes deliberately so. FDA inspections, then, are by no means the way to apply GMP uniformly.
Increasingly, manufacturers are looking to a reliable third party consultants such as Synergy Biosciences to conduct mock inspections of their facilities and provide outside verification that the plant is operating at GMP levels.
When a company invests in this exercise, it expects that a passing grade answers this question: If the FDA walked into your facility tomorrow, would it pass the government’s GMP compliance requirements?
Third-party certifiers can verify standards from their experience with the FDA and by their understanding of positive outcomes. But, perhaps too often, standards and expectations vary widely among auditing firms. While one auditor may identify processes and documents that qualify as an appropriate identity test or a sufficient qualification of a supplier—both explicit requirements of the GMP rules—that finding might not pass muster with the next auditor. This discord is unacceptable. Much like our example of weighing scales that must consistently measure 500 mg in all factories, we must standardize how (and what) third-party inspectors evaluate. Only this standardization will increase the likelihood that a firm will “pass” the FDA’s official inspection.
The pharmaceutical industry needs to establish a common measuring stick for GMP inspections so that all reputable third parties are auditing GMP compliance to the same (or at least very similar) levels. Putting all manufacturers on common ground during these audits will help reduce the chances of receiving a “483″ notice of violation from FDA. More importantly, common auditing standards help ensure that drugs, regardless of manufacturer, carry an acceptable level of quality.
A common scorecard for GMPs has other benefits. A widely agreed metric of what constitutes GMP compliance can help persuade industry-watchers (like New York’s and other state attorneys general) that their scrutiny is a waste of resources. At the very least, it could shift attention to the true outliers which ignore GMP obligations. If these firms had to endure rigorous third-party reviews, that would demonstrate that the industry is effectively self-policing—at least those companies that pursue a third-party certification. And not pursuing third-party certification would raise a much brighter red flag about that company.
Of course, the ultimate beneficiaries of a uniform third-party auditing standard are consumers. When they see a “GMP certified” seal on a supplement’s label, they will have increased confidence that the product was manufactured under strict GMP requirements. A uniform standard will help consumers make informed decisions and support products that are investing in quality that GMP regulations were designed to incentivize.
Several efforts are currently underway to make this common measuring stick for GMP certification a reality. The Global Retailer and Manufacturer Alliance (GRMA), which represents both manufacturing and retail interests, is working toward consensus of what the GMPs demand. Industry trade associations are offering support, and the Council for Responsible Nutrition (CRN), in particular, has pledged to help move this effort forward. It’s heartening to see competitors in the third-party certification arena, like NSF International, U.S. Pharmacopeial Convention (USP) and Underwriters Laboratories (UL) coming together to help raise the bar for industry.
It can’t happen soon enough. Today, quality and compliance go hand in hand. It’s not enough to say you make a quality product. More consumers and retailers are looking for confirmation that manufacturers are walking the talk. A common measuring stick for GMP compliance will allow everyone to know the value of a third-party audit investment. Just like the scales we use to weigh out ingredients, the standards for compliance should assure our consumers they are getting exactly what they expect.
Do you support the idea of a common third-party GMP auditing process? What issues do you see arising from this effort? Drop us a comment and let us know your thoughts.