Regulatory library

21 CFR Part 4

Part 4 says which CGMP rules apply to a combination product, such as a drug with a device, and how a manufacturer can meet them through one quality system.

ValDoc's library holds 1 provision of 21 CFR Part 4. This page is guidance in our words. The regulation's own text governs.

Last updated

Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. 21 CFR 4.3; 4.4(b)

    Effective

    What current good manufacturing practice requirements apply to my combination product?; How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?

    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.