Annex 1 has been published. And we are ready to help.
The highly anticipated revision to EU GMP Annex 1 has finally landed. As you might expect, in its 58 pages (up from 16 pages), it includes much more information. It also looks to remove previous ambiguities and inconsistencies while considering some of the significant technical advances made in the last 15 years.
The timescale for implementing the new Annex 1 directives is just one year. Some of the mandates won’t be sorted overnight. For instance, the revision embeds the establishment of a contamination control strategy (CCS) that includes continuous monitoring with more than 50 references. So that 12 months will fly by.
But there’s no need to panic. While we will all need to consider how the new revision impacts facilities, processes, procedures and services that are offered and received (including our own), the guidance and support that we can offer in interpreting and implanting the revised Annex 1 is available now.
Here at Validair Diamond Scientific, we are experienced, equipped, more than happy to share our knowledge and ready to help our customers meet the new regulatory challenges at whatever level they need to operate.