Annex 1 in practice in 2025
You might think that the EU GMP Annex 1 (2022) is already showing signs of patina. Far from it! After the publication of the final version in summer 2022, a lively discussion began, followed by intensive activities to create the CCS and develop new technical solutions for the aseptic setup. Initially, the authorities were rather cautious; however, inspection practice now shows a clearer picture of expectations, which unfortunately is not entirely uniform internationally.
Our CoP Aseptic Processing will be at Takeda in Linz, Austria on the 18th and 19th of November, 2025. There you will have plenty of opportunity to ask your questions about the implementation of Annex 1 for new plants and existing installations and to discuss possible solutions to popular topics during a 2-day workshop. The interactive parts of the seminar are supplemented by keynote speeches. A tour of the production facilities at the host company Takeda will deepen the discussion.
Key Details
Date
18.11.2025 09:00 a.m. – 19.11.2025 4:00 p.m.
Location
Company Takeda
St.-Peter-Strasse 25
A-4020 Linz
Austria
Language
German.
Workshop size
The number of participants is limited to 30 in order to ensure an efficient exchange.
Participation fee
The fees are per participant:
450,- € for ISPE members
750,- € for non-members – This booking option automatically includes a one-year ISPE membership.
Registration
Details on registration will follow at a later date.
Prel. Agenda
Day 1
09:00 am: Welcome, introduction of ISPE, housekeeping: J. Rauschnabel, ISPE D/A/CH CoP
09:15 am: Presentation Takeda, Linz
09:35 am: Annex 1 Practice: Aseptic Setup, First Air and Interventions (NN)
10:15 a.m: —Break—
10:45 am: Focus topic 1: Setup plug sorting (WG Appropriate Tech) incl. Discussion
11:30 am: Focus topic 2: Setup filling path (WG Cleanroom Quality/Approp.)
12:30 p.m: Lunch
13:30: Focus topic 3: Annex 1 requirements for material transfer in
(SKAN with pharmaceutical manufacturer NN, Castus…)
14:15: Workshop allocation (and short break)
14:30: 3 parallel workshops on the 3 main topics
16:30: —Break—
16:45: Report from the workshops (15 min each)
5:30 pm: Wrap up of the day and housekeeping
19:00: Evening event
Day 2
08:30 am: Welcome and housekeeping
09:00 am: Impulse 1: Smoke studies and airflow visualization
09:45 am: Impulse 2: VR training for aseptic work (practice at pharmaceutical manufacturers)
10:30 a.m: —Break—
11:00 am: Aseptic processing in the future: ideas for new filling line concepts and needs: interactive/moderated collection & discussion
12:30 p.m: Lunch
1:30 pm: Guided tour at Takeda
3:30 pm: Wrap up and farewell
16:00 hrs: End