§117.420. Using approved suppliers.
21 C.F.R. § 117.420
Approval of suppliers. The receiving facility must approve suppliers in accordance with the requirements of § 117.410(d), and document that approval, before receiving raw materials and other ingredients received from those suppliers;
Written procedures for receiving raw materials and other ingredients.
Written procedures for receiving raw materials and other ingredients must be established and followed;
The written procedures for receiving raw materials and other ingredients must ensure that raw materials and other ingredients are received only from approved suppliers (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use); and
Use of the written procedures for receiving raw materials and other ingredients must be documented.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Source
Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.