EU GMP Annex 1 · 2022 revision

How Annex 1‑ready is your sterile operation?

A short self-assessment for every department. Get your score, the right answers and the next steps to close the gaps.

12 questionsAbout 4 minutesNo sign-upFree PDF report
Choose your department
Select a department to begin
Your answers stay on your device. We don't use cookies, analytics or trackers, and nothing you answer is sent to us. Contact details are only collected if you choose to request a consultation, with your explicit consent.
01Pick your function

QA, QC, production, engineering, validation or site leadership. Each gets questions tailored to its role.

02Answer honestly

Each question is tied to a specific Annex 1 clause. "I'm not sure" is a valid answer and shows where training would help.

03Get your report

See your score by area, the compliant answer for each question with clause references, and a prioritised action list. Download it as a PDF.

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Taking the assessment: nothing is collected

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Your Annex 1 readiness score image
1
Download your score image

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2
Copy the post text

Edit it here first if you like.

3
Post it on LinkedIn
  1. Click Open LinkedIn below; the post box opens.
  2. Paste the text with Ctrl+V (⌘+V on Mac).
  3. Click the photo icon and choose the image you downloaded.
  4. Click Post.