Public Workspaces

Please review all ballot materials. When adding comments, please identify the section number/name for your comment and add all comments under one comment number where possible. If you need additional space, please use the attached blank comment template in the reference documents and upload online via the browse function.

Title Recirculation of: Approval of 455-4i46r1 - Retest
Description

Proposed revision to NSF/ANSI 455-4 – Good Manufacturing Practices for Over-theCounter Drugs (455-4i46r1) 



The proposed revision will ensure all requirements from 21 CFR 211 are included in 455-4. This also updates Section 4.5.5 to include 211.86 and 211.87, and Section 4.5.4 to include 211.87.



*This ballot is being extended for 2 additional weeks in order to collect more votes*

Ballot Options Ballot has closed
[ ] Affirmative
[ ] Negative
[ ] Abstain
Document for Approval 455-4i46r1 - Retest - JC Memo & ballot.pdf (see details in new window)
Opening Date Tue, Jun 4 2024 3:00 pm Eastern Daylight Time
Closing Date Tue, Jun 18 2024 11:59 pm Eastern Daylight Time
Ballot has closed.

Referenced Items

Name Type Date Actions

09108: Recirculation of: Approval of 455-4i46r1 - Retest

Document (Archive)

2024-06-19

No Access

gmpOTC-2023-4 455-4i46 (455-4ARGi11) Retest.pdf

Document

2024-05-09

RB Blank Comment - TEMPLATE.docx

Document

2024-05-09