s**********8
发帖数: 25265 | 1 Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Introduction
Flexibility of the QS Regulation
Applicability of the QS Regulation
GMP Exemptions
Additional Quality System Information
Quality System Regulation and Preamble1
Introduction
Manufacturers must establish and follow quality systems to help ensure that
their products consistently meet applicable requirements and specifications.
The quality systems for FDA-regulated products (food, drugs, biologics, and
devices) are known as current good manufacturing practices (CGMP’s). CGMP
requirements for devices in part 820 (21 CFR part 820) were first authorized
by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act).
Under section 520(f) of the act, FDA issued a final rule in the Federal
Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for
medical devices. This regulation became effective on December 18, 1978, and
was codified under part 820.
In 1990, FDA undertook the start of the revision of the CGMP regulation to
add the design controls authorized by the Safe Medical Devices Act. Also,
the agency believed that it would be beneficial to the public and the
medical device industry for the CGMP regulation to be consistent, to the
extent possible, with the requirements for quality systems contained in
applicable international standards, primarily, the International
Organization for Standards (ISO) 9001:1994 "Quality Systems--Model for
Quality Assurance in Design, Development, Production, Installation, and
Servicing,” and at the time the ISO committee draft (CD) revision of ISO/CD
13485 "Quality Systems--Medical Devices--Supplementary Requirements to ISO
9001.” After an extensive effort, the part 820 revision was published on
October 7, 1996 (61 FR 52602)2 and went into effect June 1, 1997. 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 52602 - 52654) to
the Quality System regulation (61 FR 52602)3.
The preamble describes the public comments received during the development
of the QS regulation and describes the FDA Commissioner's resolution of the
comments. Thus, the preamble contains valuable insight into the meaning and
intent of the QS regulation.
Flexibility of the QS Regulation
The QS regulation embraces the same "umbrella'' approach to the CGMP
regulation that was the underpinning of the original CGMP 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 820.5 of the QS regulation.
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. devices that
meet the quality system requirements. 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 allows some leeway in the details of
quality system elements. 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 820.3(l) as any device or accessory to any device that is suitable for
use or capable of functioning, whether or not it is packaged, labeled, or
sterilized.
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.
GMP Exemptions
FDA has determined that certain types of medical devices are exempt from GMP
requirements. These devices are exempted by FDA classification regulations
published in the Federal Register and codified in 21 CFR 862 to 892.
Exemption from the GMP requirements does not exempt manufacturers of
finished devices from keeping complaint files (21 CFR 820.198) or from
general requirements concerning records (21 CFR 820.180).
Medical devices manufactured under an investigational device exemption (IDE)
are not exempt from design control requirements under 21 CFR 820.30 of the
QS regulation.
Additional Quality System Information
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/P | b*******0
发帖数: 8 | 2 多谢班主，指路明灯阿
that
【在 s**********8 的大作中提到】
: Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
: Introduction
: Flexibility of the QS Regulation
: Applicability of the QS Regulation
: GMP Exemptions
: Additional Quality System Information
: Quality System Regulation and Preamble1
: Introduction
: Manufacturers must establish and follow quality systems to help ensure that
: their products consistently meet applicable requirements and specifications.
| w*********l
发帖数: 5144 | 3 马甲好新啊.处贴?
【在 b*******0 的大作中提到】
: 多谢班主，指路明灯阿
:
: that
| a*i
发帖数: 1652 | 4 Anybody please elaborate on this (thanks a lot):
"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." | w*********l
发帖数: 5144 | 5 shang xia wen?
objective
the
【在 a*i 的大作中提到】
: Anybody please elaborate on this (thanks a lot):
: "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."
| a*i
发帖数: 1652 | 6 如果让外面实验室测试数据，那我们公司要为对方的某些失误负责？
这里有什么具体含义？
the | s**********8
发帖数: 25265 | 7 没啥吧, 自己take full responsibility of using contract labs.
【在 a*i 的大作中提到】
: 如果让外面实验室测试数据，那我们公司要为对方的某些失误负责？
: 这里有什么具体含义？
:
: the
| a*i
发帖数: 1652 | 8 看来让别人合成材料也是个麻烦事。。。
【在 s**********8 的大作中提到】
: 没啥吧, 自己take full responsibility of using contract labs.
| a*i
发帖数: 1652 | 9 谢谢解答。这些管理法规什么的，如果没有联系实际情况，真的是味同嚼蜡。 | s**********8
发帖数: 25265 | 10 that's why most big pharma keep all the developmental work in house.
【在 a*i 的大作中提到】
: 看来让别人合成材料也是个麻烦事。。。
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