Proposed revision to NSF 455-4ARG - Audit Requirement Guidelines for Good Manufacturing Practices for Over-the-counter drugs (455-4ARGi9r1)
The proposed revision will update ARG to include details from CFR211 and ICH Q7.
***Please note that this is an ARG ballot only. ARG guidelines are denoted in italics and only the italic language is open for comments. While this ballot may include some suggested changes to the standard this ballot is NOT on those changes. They are only included so that you can see how those suggested changes impact the ARG. If you have any comments on the included standard changes you MUST make those comments on that issue paper’s ballot. The link to the ballot is included in the comments in the ballot. Any comments on the suggested standard changes shown in this ballot will be considered nongermane and will not be addressed.*** |
