Following a long review period, the new Annex 1 was released in August 2022 and it is now time to consider the different new and renewed requests and the impact of these requirements on our own facility and organization.
The last version, in force until 22 August 2022, was released in 2009; it was in use for more than 10 years. Then, approximately five years ago, a first version of an updated Annex 1 was published with the goal of collecting comments from the pharmaceutical industry. No limit to comments was announced.
It should be mentioned that major changes were foreseen in the updated version; to give an idea of the changes, the earlier version contained more than 20 pages while the updated one has more than 60 pages.
The 2017 updated document was the object of many discussions and disputes in the pharma community and a correspondent volume of comments and amendment requests were sent to the agency. This cumbersome amount of information took some time to be accepted, implemented and justified.
Then, in 2020 the updated Annex with comments incorporated was released for comment but open only to specific institutions.
The massive quantity of new information and subsequently requested new content contained in the new document is also due to the fact that in the past years, important implementation from a technical point of view has been developed to grant a more reliable aseptic condition along with the various processes where a sterile condition is required.