5 Expert Insights: Stay compliant amidst excipient regulation uncertainty
In the world of drug development, excipients are considered inactive ingredients. And today, they are recognized for playing a bigger role in formulations. Much more than "space fillers” or enablers of Active Pharmaceutical Ingredients delivery, there is growing awareness of the impact of excipients on the efficacy, safety and stability of medicines. This acknowledgment is driving demand for higher quality solutions that meet rigorous pharmaceutical standards. Yet, the challenge remains: in most countries, excipients are not governed by their own regulations and instead fall under broad drug regulations. Interpreting and applying drug regulations to excipients can be challenging for excipient manufacturers and pharmaceutical companies–but it’s essential if you want to ensure you are using high quality excipients in drug formulations.
That’s where IFF Pharma Solutions steps in. As a global, trusted excipient manufacturer, innovator and supplier, we understand these challenges and can offer expertise and guidance to navigate the ever-changing drug development landscape. Here, Priscilla Zawislak, Global Regulatory Affairs Advocacy Manager at IFF Pharma Solutions, shares five strategies for maintaining drug manufacturing quality and compliance when it comes to excipient choices.
Start with IPEC guidelines as your roadmap to quality
One of the first steps in certifying excipient quality is to refer to guidelines from trusted industry bodies like the International Pharmaceutical Excipients Council (IPEC). These guidelines can help pharmaceutical manufacturers navigate regulations surrounding excipients by offering frameworks for supplier qualification, risk assessment and management, and Good Manufacturing Practice (GMP) compliance.
“IPEC promotes the harmonization of excipient standards across different regions, helping to align regulatory expectations globally, said Priscilla Zawislak. “Following best practices, like those found in IPEC guidelines, reduces the burden on drug developers who operate across multiple markets, supporting them in choosing an excipient that meets the necessary standards needed for use in pharmaceutical formulations, thus minimizing risks and enhancing patient safety. IFF is well-versed in the various guidelines available from IPEC and the expectations of regulatory agencies. This knowledge means we can support manufacturers in interpreting guidelines, and, therefore, the compliance of their formulations.”
Never underestimate supplier qualification
Choosing the right excipient is not just about meeting pharmaceutical requirements – it’s also about ensuring the excipient comes from a reputable source. Supplier qualification is a cornerstone of this. On-site, third-party audits and GMP verification are essential to confirm that the excipient manufacturer complies with all necessary regulations and maintains the highest quality criteria.
“The customer should not depend on a paper audit or supplier documentation alone – this information should be verified. That’s why we place great emphasis on supplier qualification within IFF Pharma Solutions,” added Priscilla. “By using third-party audits, we ensure that our excipients meet global excipient quality standards. This level of scrutiny and unbiased verification helps our customers feel confident that we are a reliable and trusted partner, and that our excipients are safe and effective for patient use. Furthermore, globally recognized third-party certifications bring extra assurance for those customers concerned with compliance to worldwide policies.”
Check for integrity across the supply chain
The excipient supply chain is global and complex, often involving a network of suppliers, manufacturers and distributors spread across different regions before the product reaches the final customer. Given this, integrity of the supply chain is not just a priority – it’s essential for safeguarding the quality, safety and efficacy of pharmaceutical excipients, and ultimately drug products.
Priscilla emphasized the importance of a robust supply chain in the excipient industry, “We understand the intricacies of the global excipient supply chain and make it our utmost goal to bring customers peace of mind that our excipients meet the highest quality standards. This is achieved by implementing rigorous checks, comprehensive quality control measures, and making sure we maintain full traceability throughout the supply chain.”
Maximize the supplier-customer relationship
“To maximize the support of your excipient supplier, effective communication is one of my top tips for drug developers,” said Priscilla. “Given the wide range of applications for excipients, it’s essential that customers clearly communicate their specific needs. This is true even for common excipients. Knowing how they will be used allows us to ensure that the right grade is chosen, meeting both pharmaceutical regulatory requirements and the specific needs of the formulation.”
In higher-risk applications, such as parenteral uses, risk assessments become even more critical. “It is absolutely essential to maintain an open dialogue with your excipient supplier for these applications to mitigate any potential risks and avoid complications down the line.”
Be aware of regulatory uncertainty surrounding the use of certain chemicals
The excipient industry is facing a significant challenge with increasing proposals to ban or restrict certain chemicals, such as titanium dioxide or nanoparticles, due to safety concerns. While these concerns initially arose in the food industry, they are beginning to impact pharmaceuticals. Priscilla comments on what this could mean for drug developers, “The banning of such materials may limit the availability of essential excipients – and, therefore, the development of essential medicines. IFF Pharma Solutions remains at the forefront of these ongoing changes and continues to advocate for science-based regulatory decisions.”
“That said, should new regulations around certain targeted materials come into effect, our thorough preparation allows us to adapt while maintaining the quality and safety of our excipients – and by extension, our customers’ drug products.” IFF can respond swiftly to regulatory changes, ensuring continued access to safe and effective excipients as the landscape shifts. Additionally, the company has a dedicated toxicology team who is equipped to conduct new studies and gather the necessary data should regulatory bodies require further comprehensive research to support informed decision-making.
The takeaway…
The excipient industry is intricate and always evolving – but globally regulatory frameworks add extra layers of complexity. IFF Pharma Solutions is well prepared to meet ever-changing demands to deliver excipients that meet the highest quality standards and excellence. Through continuous monitoring of the landscape, advocacy for positive change, and a proactive approach to innovation, the company ensures that customers can trust in the quality, safety and compliance of its excipients.
To learn more about IFF Pharma Solutions’ world-leading excipient portfolio and expertise, visit: answercenter.iff.com.
