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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 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

- Voting Results

Voting Statistics

Number of votes cast (excluding abstentions) 3
Eligible members who have voted 3 of 8 37.5%
Eligible members who have not voted 5 of 8 62.5%

Voting Summary by Option

Options with highest number of votes are bold
Option # Votes % of Total
Affirmative 3 100%
Negative w/comment 0 0%
Abstain 0

Voting Summary by Interest Category

Interest CategoryAffirmativeNegative w/commentAbstainNot ReturnedTotal
Academia / NGO00000 (0%)
Distributor00000 (0%)
Emeritus00000 (0%)
Fabricator/Formulator00000 (0%)
General Interest00011 (12.5%)
Government00000 (0%)
Industry10023 (37.5%)
Ingredient Supplier00000 (0%)
Manufacturer00000 (0%)
Manufacturer Processes00000 (0%)
Medicine/Health00000 (0%)
Non-voting Liaison00000 (0%)
Other00000 (0%)
Other Industry00000 (0%)
Practitioner/Service Provider00000 (0%)
Product Certifier / Testing Lab00000 (0%)
Public Health / Regulatory00022 (25%)
Purchasers & Ecolabel Criteria Users00000 (0%)
Sustainability Advocate & Gov00000 (0%)
Trade Association00000 (0%)
User20002 (25%)
Water Utility00000 (0%)
Not Specified00000 (0%)
Total30058 (100%)