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Business & Regulation Standards & Regulation, Ingredients

The IPEC Story: Promoting Ingredients for Success

My mentor – and now departed friend – Lou Blecher used to say, “Excipients don’t get any respect.” He was right. For many years, excipients were the second-class components of drug development. It’s understandable why the API steals all the glory. The API is what gives a medicine its therapeutic properties, but without excipients we wouldn’t be able to deliver medicines effectively to patients. The right choice of excipients can enable companies to more readily manufacture their drug product, produce a stable dosage form, improve shelf life, help with swallowability, enhance patient safety in terms of compliance, and more. Excipients make up a huge percentage of an actual tablet – in some cases up to 99.9 percent!

Today, more and more people in the industry understand and respect the role that excipients play. And I think a lot of this comes down to the work that the International Pharmaceutical Excipient Council (IPEC) has done. The IPEC Federation is a global organization that promotes quality in pharma excipients. I’ve been involved in IPEC since its inception in 1991 and, over the course of three decades, I’ve seen the benefit of the policies and guidelines that we have created for the industry. Many companies have grown to become top-quality industry suppliers that meet globally vetted standards thanks to the work of IPEC.

There was simply no clear GMP regulation in place for excipient operations and the lack of harmonization left many in a state of confusion about what specifications and controls the sector should be using.

One of the biggest challenges with regulating pharmaceutical excipients is that most are made by chemical companies, who make materials for wider industrial use. As well as producing excipients for medicines, they will also be marketing these products to food companies, paint companies, plastics companies, and more. In fact, excipients for pharmaceutical use make up only a fraction of customers for the chemicals industry – and yet the pharma industry has specific GMP regulations for excipients because of the way in which they will be used.

When IPEC was first finding its feet, the unique challenges of the industry were not being addressed with the same level of scrutiny that was given to the production of finished pharmaceutical products or APIs. There was simply no clear GMP regulation in place for excipient operations and the lack of harmonization left many in a state of confusion about what specifications and controls the sector should be using. For example, it was quite normal for an excipient supplier to be told by one customer that its processes were exemplary, and completely unacceptable by another… a frustrating experience! Standards were being interpreted in different ways and arguments were hindering the industry. Some pharma companies wanted the standards at excipient plants to mirror their own but there are limits to what chemical companies are able, or indeed willing, to do when pharmaceuticals are such a small part of their business.

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About the Author

With David Schoneker

Global Regulatory Director, Strategic Relationships at Colorcon and Vice Chair for Science and Regulatory Policy for IPEC.

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