When Will this Ever Stop: DEG in Cough Syrup.

This short article reflects on the patient deaths connected to contaminated cough syrup from October 2022. The case is not closed yet.

DEG and Glycerine - Some Must go Back to School

I believe it was in one of my very first GMP trainings that I heard about the issue of DEG in glycerine leading to children′s death due to the use of such contaminated excipient in cough syrup. In countless GMP trainings and seminars I and we all have pointed this out to the trainees. As a laboratory head, quality control lead and qualified person I was responsible for the quality and the quality testing of glycerine in durg product establihsments for years - and within different manufacturing license holders. Even my kids know about this isue since Daddy of course brings home his work sometimes. Inside the GxP-industry everyone knows! EVERYONE! And this is not limited to Europe or the United States or even the ICH members group. And now we had another case! When will this ever stop?

Another Blow to Peoples′ Trust in Medication

During the years of Covid-19 alone the pharmaceutical industry has come under unprecedented attack from all sorts of groups trying to tear down the effectiveness, quality and even the ethicality of vaccines and sometimes of industrially produced medication altogether. The pandemic was a hayday for all those who always wanted to drag others into their own fears and false presuppositions about what the pharmaceutical industry does. Little of what is assumed there I have ever found in any company to be true. Not in the West, not in the East. But with something like this contaminated cough medication happning again, trust is shaken once more. Due to today′s extremely complex supply chains in drug manufacturing, people will rightly ask the question: what if I buy a cough syrup for my kids at my local pharmacy? How can I be sure this won′t happen to our family? And the answer is - sadly - they cannot be sure. Consumers and patients simply cannot retrieve the information needed to be sure. And they shouldn′t have to!

Spotlight on Excipients Again

Glycerine as an excipient has been on the regulatory radar for a long time. Special rules for testing were drafted ("certain excipients", whatever happened to those). Then new rules about dealing with excipient GMP were passed in the EU (there is no clear equivalent in the US to this day). But will all this be enough?

It will be important to see what the investigation of the case will yield: Who will turn out to be the supplier of the affected raw materials? Who was responsible for the lack of raw material testing? And most inportantly: why was this issue not identified in the qualification of the supplier? Did the cough medication producer rely on a third party certification instead of doing an on-site audit? And if Yes: Who was the third party organization? Who′s name is on the certificate?

If You Ever Doubt Your Role in a GMP Quality System

If You work in a pharmaceutical quality system and sometimes ask Yourself "what′s the point" of all the exactness, all the extra work in testing, documenting, reassuring, 4-eyes principle checking, computer system validating, on-site supplier auditing, contract laboratory inspecting, aseptic process simulating, stability testing, over and over training of staff, and on and on: This is the reason! Because people die if we don′t! And the huge value medication has for people is stripped from it.

For me this is the reason why I can never look at a consulting or work project simply from the viewpoint of earning money. Because that is not all I do when I deal with medication development and commercial production. That′s not the full story of what any of the GMP-people do.

If You are aware of issues such as for example the raw material testing not being done according to GMP requirements and if this leaves gaps of this magnitude, my recommendation is to:

• escalate it to Your superior as soon as You can,
• and if nothing changes: consider looking for another job, unless You want to become partially guilty of what′s coming.

This is why we do GMP. This is why what we do matters. During the last 10+ years I have written this on hundreds of flipcharts and training slides: compliance matters.