---
kind: "section"
citation: "21 C.F.R. § 1271.180"
title: "21"
number: "1271.180"
heading: "Procedures."
url: "https://uscodex.org/cfr/21/1271.180"
---

# §1271.180. Procedures.

- (a) **General.** You must establish and maintain procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps. You must design these procedures to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases through the use of HCT/Ps.
- (b) **Review and approval.** Before implementation, a responsible person must review and approve these procedures.
- (c) **Availability.** These procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical.
- (d) **Standard procedures.** If you adopt current standard procedures from another organization, you must verify that the procedures meet the requirements of this part and are appropriate for your operations.

## Notes

### Source

Source: 69 FR 68681, Nov. 24, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.