ECA publishes Q&A Document on Annex 1

The revised Annex 1 has now been in force for several months, but it is clear that not everyone finds it easy to interpret individual areas and sections. This may sometimes be due to language barriers, but sometimes also because the wording of the document itself is not entirely clear. This is why there are still many questions about Annex 1, which are not always easy to answer and perhaps offer scope for different answers.

In a recent presentation, the statement "The document contains too many details for experienced employees and companies and too few details for inexperienced employees and companies" was made. Perhaps there is some truth in this and may be the reason why many still have problems in implementing the Annex 1 requirements. For example, reasonable and justifiable risk management is required in Annex 1, which means measures should be taken on the basis of rational, justifiable risk assessments. At the same time, however, the new Annex 1 is much more comprehensive and detailed than its predecessor and therefore often leaves less scope for independent and risk-based implementation of measures.

However, it is impossible to write a "cookbook" for aseptic manufacturing or a "sterile manual" that covers every eventuality for the large number of different medicinal products and manufacturing processes. The world is too diverse for that, especially in the field of biological products, e.g. cell and gene therapies, modern vaccines etc. In this respect, Annex 1 attempts to maintain a balance between a detailed guideline and the necessary scope for product and process-related measures, although opinions differ as to whether it always succeeds in doing so.

To provide some support in the interpretation of the current Annex 1 and to provide some food for thought in terms of questions, the ECA has collected questions from participants during some conferences and courses on Annex 1 and has started to compile a Q & A paper from the answers given by the speakers to these questions. This document does not represent a universal guideline and does not reflect the opinion of the supervisory authorities. It is intended to show ways of understanding Annex 1 and to identify any relevant sections.
Further information can be found directly on the ECA Foundation website in the Q&A on Annex 1.