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Title Approval of 455-4i33r1 ADJ - Section 4.6.20
Description
Adjudication ballot - Proposed revision to NSF/ANSI 455-4 – Good Manufacturing Practices for Over-the-Counter Drugs (455-4i33r1)

An adjudication ballot for Revision 1 of NSF/ANSI 455-4, issue 33 is being forwarded to the Joint Committee for consideration. Please review the proposal and submit your ballot by August 9, 2022 via the NSF Online Workspace .

When adding comments, please use the comment template provided in the ballot and upload it online via the browse function.
This two-week adjudication ballot allows voters the opportunity to respond, change or reaffirm their vote based on the content of the comments contained herein. Included in the reference items for this ballot are the response letter to the 1 negative vote not resolved.

Voting options:
1.Affirmative: you are voting to accept the ballot document as it stands after your consideration of the unresolved negative comments.
2.Negative: You are voting to reject the ballot document as it stands after your consideration of the unresolved negative comments. Voters who change an affirmative to a negative shall cite the unresolved negative comment that caused their decision.
3.Abstain: You do not feel that you have sufficient information to make an informed decision on this issue.

Please note that if you do not return a vote in this adjudication ballot, your original vote will remain in effect.
At the close of this adjudication ballot, all results will be tallied to determine if the requirements for consensus have been satisfied.

The proposed revision adds Section 4.6.20 to ensure that the standard meets the FDA regulation not covered.
Ballot Options Ballot has closed
[ ] Affirmative
[ ] Negative
[ ] Abstain
Document for Approval 455-4i33r1ADJ - JC memo & ballot.pdf
Opening Date Tue, Jul 26 2022 5:00 pm Eastern Daylight Time
Closing Date Tue, Aug 9 2022 11:59 pm Eastern Daylight Time
Ballot has closed.

Referenced Items

Name Type Date Actions

07835: Approval of 455-4i33r1 ADJ - Section 4.6.20

Document (Archive)

2022-08-10

No Access

gmpOTC-2020-11- Section 4.7.20 (455-4i33).pdf

Document

2022-07-26

No Access

455-4i33r1 - Results for JC Ballot.pdf

Document

2022-07-26

No Access

Response letter - LaRocco negative comment.pdf

Document

2022-07-26

No Access

Blank Comment - TEMPLATE.docx

Document

2022-07-26

No Access