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Title Approval of 455-4i47r1 - Aseptic Processing
Description

Proposed revision to NSF/ANSI 455-4 – Good Manufacturing Practices for Over-the-Counter Drugs
(455-4i47r1)



The proposed revision will ensure all requirements of 21 CFR 211 are included in the standard, as well as missing requirements specific to aseptic processing.

Ballot Options Ballot has closed
[ ] Affirmative
[ ] Negative
[ ] Abstain
Document for Approval 455-4i47r1 - Aseptic Processing - JC 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

09043: Approval of 455-4i47r1 - Aseptic Processing

Document (Archive)

2024-06-04

No Access

gmpOTC-2023-5 455-4i47 (455-4ARGi12) Aseptic Processing.pdf

Document

2024-05-09

gmpOTC-2023-5 455-4i47 (455-4ARGi12) Aseptic Processing_with edits from JC meeting2023.pdf

Document

2024-05-09

RB Blank Comment - TEMPLATE.docx

Document

2024-05-09