21 CFR 606.20: Personnel
Requires blood establishments to staff collection, processing, testing, storage and distribution with enough adequately trained, experienced personnel who understand applicable requirements, and to keep out anyone whose presence could compromise product safety or purity.
Part 606, Current Good Manufacturing Practice for Blood and Blood Components · Subpart B, Organization and Personnel
Recent 483s citing 606.20
- American Red Cross Southeastern Michigan Region · Detroit, MichiganE<lucation and training ofpersonnel as documented in the Learner Management System… Sep 27, 2010
- American Red Cross Greater Alleghenies Regio · Johnstown, PennsylvaniaThe personnel responsible for the collection of blood or blood components are not… Sep 24, 2010
- American National Red Cross Heart of America Region · Peoria, IllinoisThe personnel responsible for the collection of blood or blood components are not… Aug 18, 2010
- American National Red Cross, National Testing Lab · Detroit, MichiganAnnual competency reviews and/or quality assurance process reviews of operators did… Jun 16, 2010
- American Red Cross Blood Services · Farmington, ConnecticutThe personnel responsible for the collection of blood or blood components are not… Jun 15, 2010
The regulation text
§ 606.20 Personnel.
(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]
Questions
What does 21 CFR 606.20 require?
Requires blood establishments to staff collection, processing, testing, storage and distribution with enough adequately trained, experienced personnel who understand applicable requirements, and to keep out anyone whose presence could compromise product safety or purity.
Which sections are cited alongside 606.20?
In the same 483s, investigators most often also cite 606.100 (Standard operating procedures), 606.170 (Adverse reaction file), 211.100 (Written procedures; deviations), 606.160 (Records).