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The ECA comments on the draft revision of Annex 1

| 5 May 2015 |

The ECA Foundation reacts to the concept paper that confirmed the revision of Annex 1 of the European GMP last February.

fondation ECA

The industry and its representatives were not given much time to comment on the concept paper on the revision of Annex 1 of the European GMP: from February (when the working document was published) until the end of March 2015. The ECA Foundation and its interest group, the Association des Personnes Qualifiées en Europe (association of qualified people in Europe or EQPA) did however manage to put together their feedback within the deadline. The comments submitted to the EMA were generally positive and in part covered the arguments in the concept paper. They asked for the incorporation of new technologies in the text that have been developed significantly since 2008, such as RABS, which need a clear definition. More details about airlocks were also requested, along with the addition of two new categories, E and F.
Unsurprisingly, the ECA-EQPA suggested bringing Annex 1 into line with current standards, including ISO 14644-1 requirements and in particular those related to monitoring particulates with a diameter greater than or equal to 0.5µm. There was also a request to come into line with ISO 5 for a particle limit of 5 µm (29 part/m3). Alongside this, the group of experts suggested bringing the document into line with the FDA’s aseptic guide.
Some of the clarifications deemed necessary were: the expression “Grade A air supply”, which has still not been clarified for sealing caps, even though this point was discussed extensively. All of the comments will soon be published on the ECA’s website. The first draft of Annex 1 is due to be released in October at the soonest.

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Also read : The revision of Annex 15

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