The long-awaited final version of GMP Annex 1 was published in August 2022, and with a one-year implementation period, this means that these new regulations have actually been in force since August this year. For those who have lost track for a moment, this refers to the EU regulations around so-called Good Manufacturing Practices (GMP). This Annex 1 is an extension of those regulations and describes the requirements that must be met in the manufacture of sterile medicinal products. Think of products that are administered by injection or infusion, such as vaccines or antibody-based therapies.

Holistic strategy

These new requirements are not only relevant for pharmaceutical manufacturers, but also for suppliers of single-use components and systems, says Michael Matthijssen, Sales Manager Biopharm Benelux at Parker Hannifin. ’The annex deals very specifically with the use of single-use technology and its benefits, but also describes the considerations that need to be taken into account.’ Patient safety is at the heart of the new regulations. This means minimising the risk of contamination. ’It is about the methods by which you can reduce the risks to the patient, but also about making those risks manageable and controllable. It is about a holistic strategy to manage contamination risks’, says Matthijssen.

A key way to mitigate these risks is to look closely at the number of components in your single-use system, the connections between those components and the number of different materials you use. ’With this Annex 1 in mind, I think the interaction between manufacturer and supplier in the design of the single use system becomes much more important. If we can help think about that design earlier, we can respond better to the new requirements.’ This also applies to the supply of support data. Not only for the individual components, but also for the complete, validated system. Matthijssen: ’Suppliers will have to do much more than just deliver the stuff, they will have to deliver complete data packages at component level as well as for the whole system. The burden of proof will be largely on the supplier.’

’The burden of proof will be largely on the supplier’

Michael Matthijssen

Validation protocol

Parker Hannifin works with ‘libraries’ of (sets of) components with validation and compliance with ISO11137. But when it comes to the final filling steps, i.e. when the final product is made for the patient, Matthijssen prefers a different approach. ’For these steps, compliance is obviously very strict. To overcome the risks described in Annex 1, we propose moulded disposable systems. A bespoke design with a validation protocol that is tailored to the product and process together with the manufacturer. The earlier the manufacturer and supplier coordinate in the design phase, the more targeted the Annex 1 compliance design can be used.’