Description
Annex 1 is not a list of rules for cleanrooms. It asks one question: can you show how every source of contamination is controlled, and how you know the controls work?
What you will be able to do
- Read your CCS as a whole. Check that it covers every element Annex 1 lists, puts design before procedures and monitoring, and stays alive through change control and management review.
- Understand the premises. Know what each grade is for, how pressure, airflow and airlocks protect the critical zone, and how isolators and RABS differ.
- Work safely near open product. Know what training and gowning qualification Annex 1 asks for, how to move near first air, and when to speak up and stay out.
- Respond to monitoring results. Tell an alert level from an action limit, take an excursion through to its impact on product, and know what a media fill proves and what it does not.
- Support the release decision. Know the routes to a sterile product, what QC and the QP review before certification, and how what is learned goes back into the CCS.
Who it is for
People who work in or support sterile manufacturing: production operators and supervisors, QA, QC microbiology, engineering and validation staff, and QPs new to sterile products. It also suits people at non-sterile sites who are building a contamination control strategy using Annex 1 principles. It explains what Annex 1 asks, why, and how it shows up on the floor. It is not an expert course on sterilisation validation, lyophilisation or blow-fill-seal.
Basis
EudraLex Volume 4, Annex 1; Chapter 1, 1.4(xiv) and (xv); Annex 15; Annex 16; ICH Q9(R1), section 3; ICH Q10, 4.1.
