AIFA incoming single text changes "non-essential"

Identify and categorize general cases and clarify some cases considered "borderline", to define the modalities for submitting applications and simplify procedures. These are the goals that moved the AIFA, the Italian Drug Agency, to the publication of a true single text on the "non-essential changes" to the structures, namely those that do not impact critically on local and production processes, do not involve a different intended use of the premises, does not plan to change layout of departments and for which no inspections by the Authority.

The new legal text was premiered by Luisa Stoppa, senior inspector of the Office permits AIFA workshops, at the X National Meeting of the Qualified Persons promoted by Afi (Pharmaceutical Industry Association).
"This is a real review 'historic' as well as harmonization of the previous determinations concerning - Determinations April 13, 2011, July 29, 2011, January 23, 2013, March 2, 2015 (ed) - in the light of the various applications received in during these years, "said Stoppa.

Among the main new features of the document, currently undergoing final approval and signing by the AIFA direction, you will have:
- The elimination of the identification codes of any change, as results are not exhaustive;
- The most clear and detailed definition of what is meant by "change nonessential";
- The introduction of the concept of risk;
- The reorganization of the class D changes, ie those that take place in cleanrooms considered less critical in terms of contamination, that "essential" will be considered "non-essential"; no change for class changes A, B, C.

In the case of specific changes in layout are provided some "downgrade" that will have the effect of excluding from the scope of the changes of the new single text. This will occur in the case of installation / replacement of analytical equipment for CIP, like-for-like replacement of analytical equipment for Qc, replacement of computer equipment, change or software update.
The signing is expected by the end of December, the publication in the journal should follow in January.

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