New Chapter 1 EU-GMP; Pharmaceutical Quality Systems
New Chapter 1 EU-GMP; Pharmaceutical Quality Systems
When was the last time you did a deep dive risk assessment into your entire supply chain process for your medicinal product?
At most companies I visit it is apparent that they have become well acquainted with a risk-based approach to subprocesses, deviations, or details in a process. However, you should be aware that soon another level of risk assessment may be expected. A new version of chapter 1 of the EU-GMP has been drafted and offered for consultation from September until December 2025. The current version of chapter 1 dates from January 2013, and a new version is expected to be approved and effectuated somewhere this year, or ultimately in 2027.
This new draft will include the updates that were made and effectuated to ICH Q9 (Guideline on Quality Risk Management) in 2023. An important reason to adapt ICH Q9 and now chapter 1 of the EU-GMP was a missing link between the Quality Risk Management as described and applied until then and the management of supply- and product-availability risks. It was recognized that supply chain issues and product shortages can present severe risks to patients, and that managing such risks should be considered an important issue in the Pharmaceutical Quality System. In this respect it should also be noted that supply chain issues and potential drug product shortages often arise from Quality or Manufacturing problems.
Without explicitly spelling it out it may be expected that in the future it will be necessary to consider the risk factors that may lead to supply problems and consequently drug product shortages, and to have a strategy in place to prevent such shortages and be able to implement mitigating measures against such occurrences. The strategy and related measures should also constitute an early warning system that supports effective oversight and provide a timely response to evolving Quality/ Manufacturing risks.
With these new requirements it is not only the manufacturer that needs to implement such a strategy, but in case these are different entities, the Marketing Authorisation Holder should also ensure that the potential risks to the supply chain are recognized and that appropriate actions are taken to prevent shortages. The MAH oversight should include all involved contract manufacturers, laboratories and critical suppliers. Where possible measures must be implemented to prevent manufacturing stops and supply chain issues which could negatively affect the reliable supply of the medicinal product.
So, to return to the original question: When was the last time you performed a deep-dive risk assessment of your entire supply chain for a medicinal product?
If the answer is “not recently” — or if you are unsure whether your current Pharmaceutical Quality System adequately addresses supply and shortage risks — now is the time to take a closer look.
At Progress, we help pharmaceutical companies translate evolving EU-GMP and ICH Q9 expectations into practical, risk-based strategies. From identifying critical supply chain vulnerabilities and assessing the effectiveness of your current controls to developing a robust shortage prevention and mitigation strategy, we can help you strengthen both your PQS and your oversight of the end-to-end supply chain.
Don’t wait for the new requirements to become an inspection finding. Start assessing your supply chain resilience today.
Contact Progress to discuss how we can help you prepare for the new Chapter 1 expectations — and, more importantly, build a Pharmaceutical Quality System that is ready for the risks of tomorrow.
