Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Ask....

The FDA amended the title of the Quality System Regulation, and established requirements that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to a...

Quality Metrics for Drug Manufacturing | FDA

Quality Metrics Data Reporting: This program will help FDA to address common quality issues in the pharmaceutical industry, address product shortage issues, and encourage modernization of pharmaceu...

Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP) | FDA

Update: January 31, 2024 · 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 CFR Part 820), incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulat...

US FDA Quality Management Maturity Whi..

A-GMP소통 그룹 소개 ; Advanced GMP Communication Group (A-GCG / A-GMP소통 그룹)은 현재와 미래의 GMP에 대하여 관심이 있는 제약인 등으로 구성된 모임으로 주기적인 GMP 지식공유 세미나 등을 실시하고 있습니다. 이 모임은 목표는 다음과 같습니다. Advanced GMP Communication Group에 참여하고자 하시는 분은 아래의 연락처로 연락주시면 성심성의껏 참여 방법을 설명드리도록 하겠습니다. (다만, 본...

Office of Product Evaluation and Quality | FDA

What We Do ; Implement the program areas through which medical devices are evaluated or cleared for clinical investigations and marketing, such as Premarket Notification (510(k)), Premarket Approval Applications (PMA), Investigational Device Exemptions (IDEs), Humanitarian Device Exemption (HDE), De Novo and Product Development Protocols (PDPs) programs. Protect and promote the public health by evaluating, enhancing and ensuring compliance with medical device laws through the Recall, Inspection and Audit, Registration & Listing, Allegations of ...

Quality and Compliance (Medical Devices) | FDA

FDA initiatives that promote the development and production of high-quality device design and manufacturing by medical device manufacturers.

Report on the State of Pharmaceutical Quality | FDA

2022 Report on the State of Pharmaceutical Quality (PDF - 8MB) ; 2021 Report on the State of Pharmaceutical Quality (PDF - 1 MB) ; 2020 Report on the State of Pharmaceutical Quality (PDF - 1 MB) ; 2019 Report on the State of Pharmaceutical Quality (PDF - 793 KB)

Office of Pharmaceutical Quality | FDA

What We Do ; Establish consistent, patient-focused quality standards. ; Integrate the assessment of drug applications with the evaluation of manufacturing facilities, leading to a single, more informed quality assessment. ; Identify quality problems that require corrective actions and work closely with other FDA offices if enforcement decisions need to be made.

[FDA] QSR(Quality System Regulation)이란? - 세부사항

FDA QSR(Quality System Regulation)이란? 현재 미국 FDA의 품질시스템규정을 말한다. (1997년 이전까지는 cGMP(current Good Manufacturing Practice)로 사용 되었다...

Quality Systems | FDA

Management Controls ; Inspectional Objectives · Decision Flow Chart · Narrative