How to obtain Preamble to Quality System Regulation (QSR) ?

Aphel

Involved In Discussions
#1
Hello!

Can anybody refer to the preamble of the quality system regulation as text file...or can anybody can explain how to find the preamble...???

Thank you very much for your support!

Best regards,
Aphel
 
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Ajit Basrur

Staff member
Admin
#3
Re: Preamble to Quality System Regulation

Hello!

Can anybody refer to the preamble of the quality system regulation as text file...or can anybody can explain how to find the preamble...???

Thank you very much for your support!

Best regards,
Aphel
Hi Aphel,

The Preamble can be found at http://www.fda.gov/MedicalDevices/D...ments/QualitySystemsRegulations/ucm230127.htm

I do not have a text file but a pdf is available . Refer to the attachment below.

What do you mean? Preamble? What quality system regulation?
Andy,

The preamble describes the public comments received during the development of the QS regulation (also called as QSR or 21 CFR Part 820) 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. :)

.
 

Attachments

M

maaquilino

#4
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