Regulatory library

21 CFR Part 610

Part 610 sets general standards for biological products, such as sterility, purity and potency testing, which shape what the laboratory equipment behind those tests must show.

ValDoc's library holds 1 provision of 21 CFR Part 610. This page is guidance in our words. The regulation's own text governs.

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Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. 21 CFR 610.1; 610.9; 610.10; 610.13

    Unchanged since

    Tests prior to release required for each lot; Equivalent methods and processes; Potency; Purity

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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.