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Can I just use USP33-NF28 method now?

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

8 posts Page 1 of 1
Hello everyone,

Just one quick question, here is the thing:

The USP monograph of interest has been changed in USP33-NF28, which will become official in May 1, 2010. Is there any regulatory compliance problem if I just use the USP33 monogrph method rather than the current official method?

Thanks in advance,

Terry

For what it's worth, my opinion would be that it would be fine to use. They're just giving time for others to come up to speed.

CPG,

That is a good point. Would you please share any reference to substantiate this?

Regards,

Terry

Hi Terry

The only reference I can give is that I have never seen an audit complaint or warning letter regarding anyone implementing a monograpg change 6 month rater than lets say one month before it becomes valid.

It is like CGP stated, 6month is USP and EPs "grace" period, if USP/EP want something implemented faster they have a "fast track version".

Can only give one recommendation and one caution:
It is never wrong to spend two sentences in your change history on why it is beneficial to implement early.
Also it may be polite to inform internal/external customers that you go early (for instance, if specification change, your customer will likely ask if they change later).

Krickos,

Thanks for you recommendation, that is very helpful.

Enjoy your day!

Terry

May not want to use USP 33-NF 28 just yet...

http://www.usp.org/USPNF/recall.html


Public Notices
Second Notice, January 12 First Notice, January 8


Second Public Notice
January 12, 2010

USP Provides Additional Information on Recall and Reissuance of USP 33–NF 28
With this second notice following the first notice of January 8, 2010, The United States Pharmacopeial Convention (USP) provides additional information about its recall of the United States Pharmacopeia 33 – National Formulary 28 (USP 33–NF 28) and its plans to reissue the publication.

Official Text
USP 32–NF 27 is official at this time and remains official until further notice. USP 33–NF 28, which was released on November 1, 2009 and recalled on January 8, 2010, was not scheduled to become official until May 1, 2010 and should not be used. The current official standards in USP 32–NF 27 can be used with confidence.

Reason for Recall
USP recalled USP 33–NF 28 because of errors that occurred when monographs were redesigned into a new format. The redesign was intended to improve ease of use, streamline presentation, and update and harmonize terminology, but was not intended to change any of the monograph requirements. The effort was comprehensive: all of the ~4000 monographs in the USP 33–NF 28 were redesigned, encompassing more than 4100 pages, over 4 million words, and many figures and tables. While many of the monographs were successfully redesigned, a significant number contained errors.

While USP has an Errata process for issuing corrections to USP–NF on an on–going basis, this process was inadequate to address the number of errors resulting from the redesign. Because maintaining the integrity and accuracy of its standards is of paramount importance, USP recalled USP 33–NF 28 in its entirety.

Official text in USP–NF evolves through continuous revision and appears in several publications.
While USP 33–NF 28 is being recalled as a publication, other official text related to the publication remain available and may be used with confidence, as follows:

Accelerated Revisions
Accelerated Revisions posted on the New Official Text section of the USP Web site are not affected by the recall and are official as of the dates indicated on the Web site. See: http://www.usp.org/USPNF/newOfficialText.

Other USP Publications
Other USP publications related to USP–NF are not affected by the recall because their content comes from USP 32–NF 27 and additional sources. Thus, official and authorized text in the following publications can be used with confidence:

USP Dietary Supplements Compendium
Food Chemicals Codex, Sixth Edition, and its Supplements
USP Pharmacists' Pharmacopeia, Second Edition, and its Supplements
2009 USP Dictionary
Reissuance of USP 33–NF 28
Electronic
USP plans to reissue the online and a CD version of USP 33–NF 28 in March 2010 with an official date six months after reissue. Only new and revised monographs available since the Second Supplement to
USP 32–NF 27 will be in the redesigned format.

Print
Coincident with release of the electronic forms of the publication, USP intends to reissue a print volume of new and revised monographs and other official text available since the Second Supplement to USP 32–NF 27. The monographs will appear in the redesigned format. This smaller volume, combined with official text in
USP 32–NF 27 and its Supplements without redesign will be the print version of USP 33–NF 28. Its official date will be the same as the official date of the electronic versions.

First Supplement to USP 33–NF 28
USP plans to release the First Supplement to USP 33–NF 28 at the same time as the reissued USP 33–NF 28 and with the same official date.

Further Information
USP's notices to the public about the recall and reissue of USP 33–NF 28 can be found on USP's Web site: http://www.usp.org/USPNF/recall.html

Thanks for the information.
Chapter: Admissions USP33 for reference
http://tinyurl.com/ylntudo
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