You must have a sufficient number of personnel with the necessary education, background, training, and experience to perform their assigned functions. You must have adequate resources, including facilities and equipment, to enable your personnel to perform their functions.
21 CFR Part 212 · Current Good Manufacturing Practice for Positron Emission Tomography Drugs
§ 212.10 What personnel and resources must I have?
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 212.10
Form FDA 483 observations citing this section, fiscal years 2016–2026 (Drugs).
- Personnel not qualified 7
- Lack Adequate Resources, Facilities, Equipment. 3
Amendment history
Federal Register documents that created or amended this section.
- 74 FR 65431 10 Dec 2009