Regulatory library
EudraLex Volume 4, Annex 1
Annex 1 covers the manufacture of sterile products. It asks for a contamination control strategy, cleanroom grades, qualified barrier systems such as isolators and RABS, environmental monitoring and validated sterilization.
ValDoc's library holds 9 provisions of EudraLex Volume 4, Annex 1. It can apply to URSs for biosafety cabinets, environmental monitoring, sterilization equipment and thermal sealing and welding systems, depending on their intended use. This page is guidance in our words. The regulation's own text governs.
Last updated
Thirty minutes. Bring one piece of equipment.
Baseline requirements that cite it
- Airflow performance and filtration integrity shall meet the approved protection strategy under the specified installed operating configuration.
- Particle counter sampling configuration shall be qualified to obtain representative samples at approved critical locations.
- Sealing/welding shall preserve the defined sterile boundary under approved material, handling and connection/disconnection conditions.
- and 8 more
Provisions in ValDoc's library
EU GMP Annex 1 §§2.3–2.6
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §§5.1–5.2
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §§5.3–5.7
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §§6.1–6.5
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §§6.7–6.13
Effective
EU GMP Annex 1 §§8.35–8.41
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §§9.1–9.7
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §5.9
Effective
Open the European Commission siteLast checkedEU GMP Annex 1 §§8.21–8.25
Effective
Open the European Commission siteLast checked
Other regulations
- ATEX Directive 2014/34/EU
- Directive 2000/54/EC
- EMA GMP questions and answers: nonsterile manufacture
- EMA Guideline on process validation for finished products
- EU GDP Guidelines 2013/C 343/01
- EudraLex Volume 4
- EudraLex Volume 4, Annex 2
- EudraLex Volume 4, Annex 11
- EudraLex Volume 4, Annex 13
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.