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Title Approval of 455-4ARGi12r1 - Aseptic Processing
Description

Proposed revision to NSF 455-4ARG - Audit Requirement Guidelines for Good Manufacturing Practices for Over-the-counter drugs (455-4ARGi12r1) 



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



***Please note that this is an ARG ballot only.***
Ballot Options Ballot has closed
[ ] Affirmative
[ ] Negative
[ ] Abstain
Document for Approval 455-4ARGi12r1 - Aseptic Processing - 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

09047: Approval of 455-4ARGi12r1 - Aseptic Processing

Document (Archive)

2024-06-06

 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