Regulatory library

21 CFR Part 600

Part 600 adds general requirements for licensed biological products to the drug CGMP rules, including how establishments and equipment used in their manufacture are kept and inspected.

ValDoc's library holds 2 provisions of 21 CFR Part 600. It can apply to URSs for sterilization equipment, depending on their intended use. This page is guidance in our words. The regulation's own text governs.

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Thirty minutes. Bring one piece of equipment.

Equipment it reaches

Baseline requirements that cite it

  • The sterilizer shall reproducibly execute the approved sterilization process for defined load types and configurations, meeting validated effectiveness criteria.

Provisions in ValDoc's library

  1. 21 CFR 600.11(a)-(b)

    Unchanged since

    Physical establishment, equipment, animals, and care

    Open eCFRLast checked

  2. 21 CFR 600.12(a)-(b); 610.12(a)-(d)

    Unchanged since

    Records; Sterility

    Open eCFR

Other regulations

Every regulation in ValDoc's library

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.