FDA QSR 21 CFR 820 PDF

Quality System Regulation and Preamble Introduction Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. This regulation became effective on December 18, , and was codified under part For additional information on the history and international harmonization of the revised regulation, with international standards and the Global Harmonization Task Force GHTF , see the preamble pages - to the Quality System regulation 61 FR Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device.

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Quality System Regulation and Preamble Introduction Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

This regulation became effective on December 18, , and was codified under part For additional information on the history and international harmonization of the revised regulation, with international standards and the Global Harmonization Task Force GHTF , see the preamble pages - to the Quality System regulation 61 FR Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation.

Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation that are applicable to their specific products and operations, 21 CFR Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, distribute, etc.

The responsibility for meeting these requirements and for having objective evidence of meeting these requirements may not be delegated even though the actual work may be delegated. FDA has identified in the QS regulation the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices, production processes, etc. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices.

Applicability of the QS Regulation The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR Certain components such as blood tubing and diagnostic x-ray components are considered by FDA to be finished devices because they are accessories to finished devices.

A manufacturer of accessories is subject to the QS regulation. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files 21 CFR Medical devices manufactured under an investigational device exemption IDE are not exempt from design control requirements under 21 CFR Additional Quality System Information.

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