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QC & GMPs for Excipients



By By Janeen Skutnik, NSF-DBA



Published June 11, 2013
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Recently, many in the pharma manufacturing space have begun classifying excipients as either “functional” or “non-functional.” While I understand the difference in these informal classifications — “functional” refers to any excipient that affects the bioavailability of APIs in a finished product, while “non-functional” seems to be a catch-all category that includes every other kind of excipient — I’m a bit perplexed by the need to classify excipients in this way.

After all, what excipient isn’t functional in some way? Whether an excipient supports the time release function of an API in a finished product or serves as a binding agent making it possible to manufacture tablets, they both serve an important purpose. They both have a function. Excipients aren’t simply added to a formulation to take up space; they may serve as taste-maskers, glidants, anti-oxidants, flow aids, binding agents or other purposes that facilitate the manufacturing process and improve chemical stability.

I’m concerned that categorizing excipients as “functional” and “non-functional” will divert our attention from the pursuit of quality control and GMPs for all excipients and instead lead to an increased focus on the so-called “functional” excipients. But for optimum consumer safety, all excipients require appropriate quality controls and must adhere to GMPs.

Appropriate Excipient Quality and Controls
For decades excipients were largely ignored by pharma companies, regulators and the public. This is primarily because they were wrongly considered inert ingredients. It’s interesting to note that most drug formulations contain 70% to 90% excipients. Still, in the past, most of our efforts and focus on risk, GMPs, regulations and legislation have been on APIs or finished dosage forms. The globalization of the pharma industry, combined with a focus on preventing counterfeits and adulterated products, has shined a light on the need for appropriate excipient quality and controls.

In the 1990s, long before the 2008 Heparin contamination incident, the International Pharmaceutical Excipients Council (IPEC) saw a need for excipient GMPs and established them. In 2006, IPEC partnered with PQG out of the UK to develop the IPEC-PQG GMPs for Pharmaceutical Excipients. Most recently, IPEC partnered with NSF International to develop NSF-IPEC 363, which will become an ANSI standard.

FDASIA and Excipients
The Food and Drug Administration Safety and Innovation Act (FDASIA) includes several provisions focused on ensuring safety and quality in the increasingly globalized pharma supply chain. Importantly, this applies to suppliers of excipients as well as APIs. And the law does not differentiate between “functional” and “non-functional” excipients.

Most manufacturers know how to adhere to GMPs for their finished products, but FDASIA now requires manufactures to verify and document that the raw materials used in finished products are also meeting appropriate GMPs. In the past, many manufacturers relied on ingredient testing or questionnaires sent to suppliers to assure GMPs. This is no longer sufficient. To comply with the FDASIA, manufacturers will need to audit their ingredient suppliers themselves or use a third-party auditor to verify the quality and safety of raw materials. This presents a special challenge, since most excipients are manufactured in bulk and sold to many industries, not just pharma. And typically the pharma industry isn’t the largest buyer of these excipients. For example, only .02% of cellulose is used in pharma products.

The industry will need to work closely with its excipient manufacturers to ensure they are manufacturing ingredients with the appropriate GMPs in mind.


Janeen Skutnik is a partner at NSF-DBA, part of NSF Health Sciences, a division of NSF International. NSF-DBA has more than 30 years of experience in consulting, training and auditing services for the pharma industry. She can be reached at jskutnik@nsf-dba.com.


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