Revised USP General Chapter <661> Containers-Plastics

Recommendation
13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
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>.
Related GMP News
05.02.2025New EDQM Guide on Compliance and Safety of Food Contact Materials
23.01.2025EU Ban of BPA and other Bisphenols in Food Contact Materials
11.12.2024New Ph. Eur. Chapters on COC, COP and SBC approved
13.11.2024Revised USP Chapter <383> Cured Silicone Elastomers
09.10.2024GMP Requirements for Ready to Sterilize (RTS) and Ready to Use (RTU) Containers
11.09.2024New Edition of the EDQM Guide on Metals and Alloys