Source: https://www.law.cornell.edu/cfr/text/21/1271.150
Timestamp: 2018-03-22 06:25:52
Document Index: 51411261

Matched Legal Cases: ['art 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', 'arts 210', 'arts 210', 'art 820', 'art 1271', 'arts 210']

21 CFR 1271.150 - Current good tissue practice requirements. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter L › Part 1271 › Subpart D › Section 1271.150
§ 1271.150 Current good tissue practice requirements.
(a)General. This subpart D and subpart C of this part set forth current good tissue practice (CGTP) requirements. You must follow CGTP requirements to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps do not contain communicable disease agents, that they are not contaminated, and that they do not become contaminated during manufacturing). Communicable diseases include, but are not limited to, those transmitted by viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents. CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. The CGTP provisions specifically governing determinations of donor eligibility, including donor screening and testing, are set out separately in subpart C of this part.
(b)Core CGTP requirements. The following are core CGTP requirements:
(1) Requirements relating to facilities in § 1271.190(a) and (b);
(2) Requirements relating to environmental control in § 1271.195(a);
(3) Requirements relating to equipment in § 1271.200(a);
(4) Requirements relating to supplies and reagents in § 1271.210(a) and (b);
(5) Requirements relating to recovery in § 1271.215;
(6) Requirements relating to processing and process controls in § 1271.220;
(7) Requirements relating to labeling controls in § 1271.250(a) and (b);
(8) Requirements relating to storage in § 1271.260 (a) through (d);
(9) Requirements relating to receipt, predistribution shipment, and distribution of an HCT/P in § 1271.265(a) through (d); and
(10) Requirements relating to donor eligibility determinations, donor screening, and donor testing in §§ 1271.50, 1271.75, 1271.80, and 1271.85.
(c)Compliance with applicable requirements -
(1)Manufacturing arrangements (i) If you are an establishment that engages in only some operations subject to the regulations in this subpart and subpart C of this part, and not others, then you need only comply with those requirements applicable to the operations that you perform.
(3) With the exception of §§ 1271.150(c) and 1271.155 of this subpart, the regulations in this subpart are not being implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the Public Health Service Act and the regulations in this part, or for the establishments that manufacture them.
(d)Compliance with parts 210, 211, and 820 of this chapter. With respect to HCT/Ps that are drugs (subject to review under an application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act or under a biological product license application under section 351 of the Public Health Service Act) or that are devices (subject to premarket review or notification under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act), the procedures contained in this subpart and in subpart C of this part and the current good manufacturing practice regulations in parts 210 and 211 of this chapter and the quality system regulations in part 820 of this chapter supplement, and do not supersede, each other unless the regulations explicitly provide otherwise. In the event that a regulation in part 1271 of this chapter is in conflict with a requirement in parts 210, 211, or 820 of this chapter, the regulations more specifically applicable to the product in question will supersede the more general.
(e)Where appropriate. When a requirement is qualified by “where appropriate,” it is deemed to be “appropriate” unless you can document justification otherwise. A requirement is “appropriate” if nonimplementation of the requirement could reasonably be expected to result in the HCT/P not meeting its specified requirements related to prevention of introduction, transmission, or spread of communicable diseases, or in your inability to carry out any necessary corrective action.