The draft Annex 1 revision remains much discussed and much debated. On May 3, the PDA Ireland Chapter hosted an all-day conference in Dublin on the revision and its potential impact. This event provided an opportunity for attendees to comment on the revisions and gain clarity on specific parts of Annex 1. Below are some key takeaways from the discussion.
(l-r) Ann McGee, Siegfried Schmitt, Lucia Ceresa and Declan Quinlan
First, contamination control strategies and quality risk management (QRM) emerged as some of the most important themes regarding updates to the original document. For example, the original document only had 21 mentions of QRM. Now, the term is referenced 132 times in the draft.
The aim of a contamination control strategy is to define the ethos of a site’s approach to contamination control. How are existing controls defined? How will they be enhanced? How frequently will they be reevaluated? And how will QRM be integrated into the strategy, proving there is less reliance on end testing? Every area should be involved in generating a contamination control strategy for a site (with the exception perhaps of HR and Finance!).
The Annex 1 revision has been developed with innovation in mind. If QRM is done well, it can be used as a tool to drive innovation and continuous improvement, however, the industry needs a mature QRM process if we are going to deal with all the risk management expectations in this revision. At the same time, the biggest challenge for Annex 1 implementation is the execution of risk management and incorporating risk culture into organizations—an indicator of maturity of a QRM program is the people involved in performing risk assessments.
When it comes to risk, we must ask ourselves, are we translating our risk information and data into true knowledge management? Are operators and analysts gaining the true knowledge during training of the “why” we do things in procedures to mitigate risk? After all, knowing your risks is a good thing—organizations should not be afraid to speak to regulators about their risks and how they are managing them.
In the opinion of regulator Ciara Turley of the Irish Health Products Regulatory Authority, the revised Annex 1 should result in fewer deviations and better supply chain integrity. In fact, she highlighted that Ireland has embraced the revised Annex 1 and most companies are in a very good position regarding the draft revision due in part to HPRA’s strong expectation.
The comments received on the Annex 1 draft have been reviewed. it was stated that there will not be a second consultation period for the updated document. Due to constraints, the final version may not be issued by the European Commission until 2020. Still, the regulators urged companies not to wait for the final publication as there may only be a minimal grace period before regulatory observations will be received. In fact, it was suggested it could be as little as three months. It is important that companies read the draft, carry out a detailed gap analysis and embrace the changes. PDA’s Ireland Chapter will continue to provide information to its members about the Annex 1 revision as it becomes available.
PDA Who's Who
- Ciara Turley, Inspector, Irish Health Products Regulatory Authority