Revised USP General Chapter <661> Containers-Plastics

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

The revised USP General Chapter <661>  (Containers-Plastics) will be published in USP 39-NF34 with an official date of May 1, 2016.

Including Changes to the title of General Chapter <661> (new title: Plastic Packaging Systems and their Materials of Construction), sections of General Chapter <661>  moved into new General Chapters <661.1> (Plastic Materials of Construction) and <661.2> (Plastic Packaging Systems for Pharmaceutical Use). The General Chapter <661.1> gives information on the comprehensive characterization of a plastic material, while General Chapter <661.2> covers testing methods and standards for packaging systems made of plastic.

The Drafts of the above mentioned General Chapters were proposed for comment in Pharmacopeial Forum 39(5) and 40(5).

All modifications will become official on May 1, 2016.

Additionally, a Draft of a new USP General Chapter <1661>  (Evaluation of Plastic Packaging Systems and their Materials of Construction with respect to their user safety impact) was proposed in Pharmacopeial Forum 40(6).

Following your registration on the USP Pharmacopeial Forum  website you can get to the complete Drafts of  USP General Chapters <661>, <661.1> ,<661.2> and <1661>.