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Title Approval of 455-4ARGi11r1 - Retest
Description

Proposed revision to NSF 455-4ARG - Audit Requirement Guidelines for Good Manufacturing Practices for Over-the-counter drugs (455-4ARGi11r1)



The proposed revision will ensure all requirements from 21 CFR 211 are included in 455-4. Update 4.5.5 to include 211.86 and 211.87 and 4.5.4 to include 211.87. Update ARGs for both.



***Please note that this is an ARG ballot only.***
Ballot Options Ballot has closed
[ ] Affirmative
[ ] Negative
[ ] Abstain
Document for Approval 455-4ARGi11r1 - Retest - Memo & ballot.pdf (see details in new window)
Opening Date Thu, May 9 2024 4:00 pm Eastern Daylight Time
Closing Date Thu, May 30 2024 11:59 pm Eastern Daylight Time
Ballot has closed.

Referenced Items

Name Type Date Actions

09049: Approval of 455-4ARGi11r1 - Retest

Document (Archive)

2024-05-31

 No Access

RB Blank Comment - TEMPLATE.docx

Document

2024-05-09

455-4ARGi11 (455-4i46) Retest.pdf

Document

2024-05-09