21 CFR 820 - Missing Numbers - I have a reference to 820.84

D

Debbie Kerr

#1
Why are there missing numbers in the 21 CFR 820? I have a reference to 820.84 but it is not in the official document. There are other "gaps" as well.

Thanks.
 
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GStough

Staff member
Super Moderator
#2
Re: 21 CFR 820 - Missing Numbers

I moved this thread to the FDA forum since it seemed more appropriate. However, if another moderator or admin feels that there is a better location, please feel free to move it.
 
M

MIREGMGR

#4
21CFR820 is a small part of the Code of Federal Regulations, a legal document with (generally) force of law. Traditionally, an attempt is made to never change the numbering of a section or topic in a published US law after first assignment, during the earliest drafting phase. Thus there is no re-numbering, and any section numbers that are assigned to sections that later are deleted and/or replaced remains missing from the overall numbering system.
 

Ajit Basrur

Staff member
Admin
#5
I moved this thread to the FDA forum since it seemed more appropriate. However, if another moderator or admin feels that there is a better location, please feel free to move it.
Gidget - you did a perfect thing :agree1:

Why are there missing numbers in the 21 CFR 820? I have a reference to 820.84 but it is not in the official document. There are other "gaps" as well.

Thanks.
Debbie,

FDA renumbered § 820.84 as § 820.72. Refer 21 CFR - Page 30 of 62 for the following text -

137. A few comments stated that it is unclear what is meant by the requirement in proposed § 820.84 Inspection, measuring, and test equipment that equipment be capable of producing ‘‘valid results.’’ The comments stated that such equipment may be ‘‘suitable for its intended purpose’’ and still not always ‘‘produce valid results.’’

FDA believes that the term ‘‘valid results’’ is commonly understood and
notes that it has been in the original CGMP regulation under § 820.61 for 18
years. The requirement is for the equipment to work properly, thereby
providing ‘‘valid results.’’

FDA renumbered § 820.84 as § 820.72 in response to comments that stated these requirements were more appropriate under subpart G Production and Process Controls. FDA revised the requirement in new § 820.72(a),‘‘Control of inspection, measuring, and test equipment,’’ to make clear that the procedures must also ensure that the equipment is maintained and moved the requirement that the procedure include provisions for handling, preservation and storage of equipment from § 820.84(d) in the Working Draft to § 820.72(a). FDA deleted the term ‘‘test software’’ that was in § 820.84(e)
because FDA believes that ‘‘test software’’ is now covered under ‘‘electronic inspection and test equipment’’ in § 820.72(a).
 
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