21 C.F.R. § 606.20

Personnel

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(a) [Reserved]

(b) The personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood or blood components shall be adequate in number, educational background, training and experience, including professional training as necessary, or combination thereof, to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess. All personnel shall have capabilities commensurate with their assigned functions, a thorough understanding of the procedures or control operations they perform, the necessary training or experience, and adequate information concerning the application of pertinent provisions of this part to their respective functions.

(c) Persons whose presence can adversely affect the safety and purity of the products shall be excluded from areas where the collection, processing, compatibility testing, storage or distribution of blood or blood components is conducted.

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 62 FR 53538, Oct. 15, 1997]

Notes of Decisions

Cited in 1 case, 1997–1997 · leading case: United States v. Maniago, 987 F. Supp. 234 (S.D.N.Y. 1997).

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United States v. Maniago, 987 F. Supp. 234 (S.D.N.Y. 1997). “Carden states that “exams” such as those at issue here are often used by FDA examiners in determining whether blood centers are complying with the requirement that all “personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood…”

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