Regulatory library

EudraLex Volume 4, Annex 15

Annex 15 covers qualification and validation. It asks for a user requirements specification, design, installation, operational and performance qualification, requalification when things change, and documented change control.

ValDoc's library holds 9 provisions of EudraLex Volume 4, Annex 15. It can apply to URSs for biosafety cabinets, centrifuges, cryogenic systems, controlled temperature units, environmental monitoring, incubators, label printers, stability chambers, sterilization equipment, transport systems, thermal sealing and welding systems and vacuum pumps, depending on their intended use. This page is guidance in our words. The regulation's own text governs.

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Equipment it reaches

Baseline requirements that cite it

  • The site shall approve a risk-based qualification strategy and trace applicable URS requirements to design review, installation, operating and performance evidence with deviations resolved before release.
  • The equipment shall perform the approved intended use over the specified capacity and operating envelope, with installation access for cleaning, inspection and maintenance.
  • If used for photostability, the system shall control and document the approved light-exposure conditions and separate unintended thermal effects as required by the approved protocol.
  • and 22 more

Provisions in ValDoc's library

  1. EU GMP Annex 15 §§1.1–1.8

    Effective

    Open the European Commission siteLast checked

  2. EU GMP Annex 15 §§2.2–2.10

    Effective

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  3. EU GMP Annex 15 §§3.2–3.3

    Effective

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  4. EU GMP Annex 15 §§3.4–3.9

    Effective

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  5. EU GMP Annex 15 §§3.10–3.14

    Effective

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  6. EU GMP Annex 15 §§4.1–4.2;11.2–11.7

    Effective

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  7. EU GMP Annex 15 §§10.1–10.15

    Effective

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  8. EU GMP Annex 15 §§6.1–6.4

    Effective

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  9. EU GMP Annex 15 §§7.1–7.2

    Effective

    Open the European Commission siteLast checked

Other regulations

Every regulation in ValDoc's library

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Thirty minutes. Bring one piece of equipment.