Help! I've missed the Annex 1 deadline of August 2023 to fix things. What do I do now?
Challenge from the Client
The client is a small pharmaceutical company with limited quality resources to devote to a full Annex 1 review and therefore had to direct their quality resources to processing batches rather than to ensure full compliance with the 'new' Annex1.
They were worried that they were too late to do a review and fix things and therefore did not even know where to begin.
Our Approach & Solution
Having passed the Annex 1 August 2023 deadline, it is important to recognize that quality and regulatory compliance is not a defined point in time but part of a continuous process of improvements. We understand that advancements in technology and processes are faster than ever. Even standing still is going backward.
Clients welcome having a non-judgmental expert assist them first to identify Annex 1 Gaps in their facility, to risk assess those gaps and then help embark on a process of remediation. Uniquely to IPS, often to actually engineer those fixes as well. A one-stop shop. IPS’ skillset and knowledge leaders help achieve fixes that are designed to suit clients’ pockets. Importantly, It is not too late for those companies that have missed the deadline.
Help is at hand. It is far better to have an improvement plan in place than none at all! Breaking the inertia of the 'rabbit in the headlights' is the first step in this process. IPS experts have the wisdom to get you started on the path of successful compliance.
The Results
The palpable relief of having external subject matter experts assess, recommend and fix items against both Annex 1 and benchmark to industry expectations helps smaller companies achieve their compliance goals.
Ultimately, helping clients become compliant helps keep patients served with life-saving medication.
Doing the right thing because it’s the right thing to do.
