EU GMP Annex 1: The Cost of Non-Compliance

The new GMP Annex 1 standards will enter into force on 25 August 2023 (except for Chapter 8.123, which is postponed until 25 August 2024), and all organisations involved in the manufacture, transport, packaging and distribution of sterile medicinal products must make sure that necessary provisions have been put in place and tested by that deadline in order to be compliant. Time is ticking away, and the approaching deadline may be giving you cause for concern if you are uncertain about your own organisation’s preparedness.

What Will Happen if My Organisation Isn’t Ready in Time?

The initial draft of the revision of Annex 1 was published in December 2017, so we’ve all been aware that change was coming for several years. This is no sudden shock to the system; we’ve all had ample time to adjust. So, in all likelihood, you’ve already been travelling in the direction of compliance for some time. But let’s say, for argument’s sake, that you fall far short of the minimum requirements of the Annex when the deadline arrives. What then? It’s simple: you won’t be able to go on doing what you do. Manufacturing, transport, packaging and distribution will all come to a grinding halt.

The Human and Financial Cost of Failure

The purpose of the new Annex is to provide clear guidance to organisations involved in the manufacture of sterile medicinal products; its focus is on driving improvement for the benefit of patients, to protect them from any potential ill effects of contamination, which can reduce the therapeutic effect of a drug or even render it inactive or dangerous. But proper checks and controls don’t just protect the patient who uses the drug, they protect the company that manufactures it; any contamination event in the drugs manufacturing process can have an immense financial impact on the organisation involved.

In 2010, McNeil Consumer Healthcare, a subsidiary of Johnson and Johnson, was forced to close its plant in Fort Washington, Pennsylvania, and issue mass recalls, when metal particles were found in bottles of its infant and child medicines. Five years of litigation with the FDA followed (during which time the plant was forced to remain closed) and resulted in the company being issued with a $25 million criminal fine in 2015.¹

A year earlier, Genzyme was forced to close its Massachusetts plant temporarily following contamination events, resulting in shortages of two drugs: Cerezyme (for Gaucher disease) and Fabrazyme (for Fabry disease); both diseases can cause life-threatening organ damage without treatment and, at the time, Genzyme was supplying 8,000 patients globally. The company paid $175 million in fines.²

Failure to prevent contamination of sterile medicinal products can result in a number of damaging consequences, including costly product recalls, denied approvals, plant closures, heavy fines and severe damage to an organisation’s reputation.

What Do I Need to Do?

In order to prepare for the deadline, it’s important that you fully understand the requirements of the Annex, but it’s also important that you fully understand your own facilities and processes and that you have performed a thorough analysis to identify any gaps that need to be addressed. Only then will you be able to make necessary changes, or at the very least make sure that necessary change is well underway, before the deadline.

What if My Organisation Isn’t Based in the EU or UK?

Wherever your company is based, if you export into the EU and UK Annex 1 applies to you. In addition, you may not be selling into the EU and UK right now, but do you have plans to? If you do, you need to plan for Annex 1 compliance. If you’re in the process of building a facility right now, even if you have no plans to export to the EU and UK for a few years, you need to factor in the requirements of Annex 1 now; either that or face costly alterations in a few years’ time. Whatever your plans may be, whatever timeframe you have in mind, if you plan to export to the EU and UK, it’s never too soon to begin planning for Annex 1 compliance.

So, How Can We Help You?

We are supported by a pool of highly experienced QPs and are able to provide advice and guidance to help you achieve and maintain Annex 1 compliance. If you have questions about the new Annex 1 requirements and what your organisation needs to do to be compliant, or you are concerned about how regulatory authorities may enforce the requirements, please get in touch.



¹ Reuters (2015), Tylenol maker to pay $25 million for selling metal-contaminated drugs.

² Financial Times (2010), Genzyme fined $175m over manufacturing failures.


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