The clock is ticking.

In August 2023, the EU GMP Annex 1 Revision will take effect. Facilities that do not comply with the new standards risk shutting down their manufacturing lines or losing market share in the EU. While these are EU standards, they will reach any manufacturing line that hopes to do business in the EU, which is to say that Annex 1 implementation should be considered universal. The US Food and Drug Administration had a hand in drafting Annex 1 regulations to bridge any real or perceived regulatory gap.

The urgent news is that action is required. While many large and international firms headquartered in the US have most certainly begun the process, many smaller companies and startups still need to catch up. Many companies may be paralyzed by indecision. Their inability to take basic steps now will guarantee the immobility of the process lines very soon.

Companies that have successfully navigated the Annex 1 revisions share two common traits: their modern facilities complied from the start, or they successfully interrogated their contamination control strategy with an understanding of the regulations in mind and are putting into place a mitigation plan. Those in the former category are rare; all should assume they are in the latter.

To comply with Annex 1, organizations should immediately perform three tasks.

First, read Annex 1 and note what regulators will look for concerning contamination control. The rules are written in English, but not necessarily in plain language. In the era of contract manufacturing outside of Europe and North America, this has often led to cultural and linguistic misinterpretation. Representatives from across an organization, with a hand in every aspect of manufacturing, should take part in reading the Annex 1 revisions. Together, they should work to ensure they share a common understanding of the regulations, particularly if manufacturing team members come from different cultural backgrounds.

Second, perform a gap assessment. Representative experts across the organization should critically examine every facet of the operation, from gowning to fit and fill, to understanding potential deficits.

Third, document everything. Compile findings from across the facility and its processes, noting where points of compliance as well as where gaps exist. This assessment will dictate how an organization can build a contamination control strategy. Even now, regulators are looking for mitigation procedures to see that a facility has plans to meet Annex 1 requirements. Regulators will look even more closely in August. Organizations will fare much better if they have a current contamination control strategy and are taking steps to bridge gaps.

The Annex 1 revisions do not come at an ideal time, which is an understatement. The current era has seen extraordinary success in the pharmaceutical industry in adapting to realize the potential of new ATMP therapeutics and to respond in full force to an emergent global pandemic. The current era has also seen massive, problematic drug shortages and associated supply line impacts.

Early drafts of the EU GMP Annex 1 revision were released in 2017, and any company that has not yet given thought to compliance will expect some challenging times ahead. While time is of the essence, there is still time left.

The rest of the industry needs to come on board with these more stringent standards, and the time to act is now. There is no time left to consider panicking; one must either assess their risks and make purposeful steps toward compliance or prepare for stoppages until forced to comply.

Meanwhile, the clock continues to tick toward August.