GMP topical


EMA: Concept Paper on the Revision of EU GMP Annex 11 on Computerised Systems

EMA: Concept Paper on the Revision of EU GMP Annex 11 on Computerised Systems

On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 "Computerised Systems". The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA.

In short:

A new focus is to be on data integrity, in particular the requirements for "data in motion", and data in archives or in backup, the so called "data at rest". The requirements for providers of e.g., cloud services are also to go into more detail and the meaning of "validation and qualification of the systems" is to be clarified in greater depth. This also applies to the term "commercial off-the-shelf products". References to ICH Q9 and thus to quality risk management will also be added.

In addition to these classic topics, developments in the field of artificial intelligence will be included in the future. There are currently no regulatory guidelines or expectations for AI (artificial intelligence) or ML (machine learning). The main focus here should be on the relevance, appropriateness and integrity of the data with which these models are tested and, on the results (metrics) of such tests.

Of interest is a reference (33.) to the FDA's draft document "Computer Software Assurance for Production and Quality System Software", which was recently published. This important US document is to be reviewed for possible regulatory relevance to Annex 11.

The timeline for a new Annex 11:
The consultation period ends on 16 January 2023, with a draft document to be released for consultation in December 2024. Finalisation of the document is planned for 2026.


EMA: Concept paper on EU Annex 11 on Computerised Systems