In this 2-part Q&A, Peter Zambetti, director of global business development at Capsugel and chairman of the International Alliance of Dietary Supplement Associations (IADSA), talks turkey on GMPs and other regulatory must-dos.
What are your predictions regarding global oversight of the H&N industry?
There certainly will be more regulation in the future, along with increasing scrutiny. I believe tightening the regulations that govern product quality is an important step forward for the industry, and I welcome the government’s efforts to encourage that process by stepping in to implement GMPs (Good Manufacturing Practices).
Customers are well informed about safety concerns and need to be reassured that their supplements are safe and reliable. Put simply, the H&N industry needs to recognise the benefits to be gained by advocating for tighter regulations and improving their practices to comply with those standards. These benefits include heightened consumer confidence and satisfaction and, as a result, the potential of increased sales of H&N products.
Can you explain GMPs and why they are important?
GMPs are a system for ensuring that products are consistently produced and controlled according to quality standards. GMPs cover all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each manufacturing process that could affect the quality of the finished product.
The United States has issued enforceable GMPs covering foods, food supplements and other products. The Association of South East Asian Nations (ASEAN) is currently working toward similar regulations. It would be great to see the European Union promulgate GMPs for food or food supplements as well.
Some companies, including Capsugel, have taken an active role in supporting the development of global standards and working with regulatory authorities to adopt them. Meanwhile, at IADSA, we’ve made it our goal to spread the word about the importance of GMPs.
About two years ago we issued a global GMP guide for regulators, companies and educators around the world. The IADSA guide, which is available to anyone at www.iadsa.org, offers a succinct description of GMPs and a practical approach to complying with these guidelines.
Can you point to any successes regarding IADSA’s GMP educational efforts?
In Brazil, IADSA has worked closely with ANVISA (Brazil’s equivalent of the European Medicines Agency (EMA)), along with the local dietary supplement trade association, ABIAD, to use some principles of the GMP regulations to speed the approval process. Regulatory restrictions loosened as a result, which helped vitamin sales and produced other tangible benefits.
For example, multivitamins may now be distributed to and bought in supermarkets rather than just in pharmacies – certainly a positive change. And ANVISA now asks for notification of new vitamin and mineral products rather than requiring registration – an expensive process that can take 18 months.
Supplements including botanicals still require registration to gain marketing approval in Brazil, but these changes are steps in the right direction for manufacturers and consumers alike.
With respect to the quality of capsule manufacturing worldwide, where do you think the problem areas are?
Some growing markets do have capsule manufacturers with raw material issues. For this reason, H&N companies need to be very careful about testing their incoming capsules. Not long ago, the H&N industry regarded capsules as merely shells to contain their products, but they are beginning to be recognised as integral to proper dosage forms and safe ingestion. Choosing the wrong capsule can, and does, have negative consequences for a company’s brand.
Would implementing GMPs in Europe affect the way Capsugel operates?
Capsugel is already in compliance with US GMP standards and has been for years. For more than a decade, Capsugel’s robust safety assurance program has upheld a high level of GMPs. For example, when chromium was detected in Chinese gelatin capsules in 2012, the United States Pharmacopeia-National Formulary issued a Revision Bulletin requiring that raw pharmaceutical grade gelatin be tested for chromium and other heavy metals.
Because we already ran these tests as standard operating procedure, Capsugel was unaffected by the issue.
Look for part 2 of this Q&A next week on NutraIngredients where Zambetti will focus on the impact of health claim regulations in global markets...