Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>
Recommendation
15/16 October 2024
How to ensure GMP compliant Development and LIfe-Cycle-Management for Drug-Device Combination Products
The USP Expert Committee General Chapters—Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661.1> and <661.2>. The revisions of the four general chapters have become official on May 1, 2017.
As reported under "Three-year period for implementation of USP Plastic Packaging Chapters <661.1> and <661.2>" the reason for the revisions is
- to provide a three-year period for implementation of the requirements specified in General Chapters <661.1> and <661.2>, which otherwise will become applicable on May 1, 2017 through General Chapter <659>;
- to reinstate requirements previously expressed in General Chapter <661> during this three-year period;
- to enable early adoption of the requirements in General Chapters <661.1> and <661.2> at any time during the three-year period instead of meeting the reinstated <661> requirements; and
- to remove the current exemption to General Chapters <661.1> for previously approved packaging systems.
To find more details please see the USP Official Text.
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