How mature is your Contamination Control Strategy?
Rate 19 checkpoints against Annex 1. See your CCS as a ring, find the gaps that matter most, and leave with a 90-day plan.
From "not in place" to "effective and reviewed". Every checkpoint is one of the CCS elements Annex 1 lists, with what the guideline expects.
Each checkpoint becomes one dot. The orange dot marks the single gap that matters most.
Priority gaps with practical actions, a 90-day roadmap and a PDF you can take into management review.
Your score by area
How mature each part of your CCS is.
Your top priority gaps
Ranked by how large the gap is and how central the element is to Annex 1. Start at the top.
Your 90-day plan
Built from your gaps. Adjust to your site's calendar and resources.
All 19 checkpoints
Open any checkpoint to see what Annex 1 expects and what to do next.
Contamination control is all we do.
Omnicon Instruments is a pioneer in empowering the pharmaceutical industry with innovative solutions, helping cleanroom professionals maintain the highest standards of contamination control. We help sterile manufacturers turn the Annex 1 Contamination Control Strategy from a document into a working system.
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This self-assessment is for awareness and planning purposes only. It rests on your own ratings. It is not an audit, inspection or regulatory opinion, and it does not certify compliance with EU GMP Annex 1 or any other regulation. The 16 elements are those listed in section 2.5 of EudraLex Volume 4, Annex 1 "Manufacture of Sterile Medicinal Products" (C(2022) 5938 final, 22 August 2022), plus three checkpoints for the CCS as a whole (sections 2.3, 2.6 and 3.1). Maturity levels and priority ranking are Omnicon's own scoring method, not part of Annex 1. Always refer to the full guideline and your own quality system.