eCFR :: 21 CFR Part 820 -- Quality System Regulation
(1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
CFR - Code of Federal Regulations Title 21 - Food and Drug …
2024年12月24日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file formats, see...
Quality Management System Regulation: Final Rule - FAQ
2024年11月21日 · On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more...
QS Regulation/Medical Device Current Good Manufacturing …
2024年1月31日 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21...
FDA-21 CFR 820 质量体系规范-中英文对照版本 - 道客巴巴
2023年7月17日 · 内容提示： ~ - 1 - ~[code of federal regulations][联 联 邦 邦 法 法 规 规][title 21, volume 8][ 标题 21 ，第 8 卷][cite: 21 cfr 820][ 引用：21 cfr 820]title 21--food and drugs标题 标题21--食品和药品 食品和药品chapter i--food and drug administr第 第i 章--食品和药品管理局 食品和药品管理局ation department of health and humanservices卫生与 ...
21 CFR Part 820 - LII / Legal Information Institute
Subpart F—Identification and Traceability (§§ 820.60 - 820.65) Subpart G—Production and Process Controls (§§ 820.70 - 820.75) Subpart H—Acceptance Activities (§§ 820.80 - 820.86)
2024 Final Rule: 21 CFR Part 820 Revision •Revises Part 21 Code of Federal Regulations (CFR) Part 820 – established October 1996 – referred to as QS regulation 8
21 CFR Part 820 Subpart B -- Quality System Requirements
§ 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (b) Organization.
21 CFR 820 - QUALITY SYSTEM REGULATION - GovInfo
2011年4月1日 · Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) Subchapter H - MEDICAL DEVICES
eCFR :: 21 CFR Part 820 Subpart A -- General Provisions
(1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
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