New Ph. Eur. Draft for COC
Recommendation
Thursday, 29 October 2026 9 .00 - 17.15 h
AI/ML-based Methods for Optimizing Pharmaceutical Research Processes
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
A revised draft for the recently proposed Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published in Pharmeuropa 34.1. The proposed general chapter has already undergone public consultation in Pharmeuropa 32.3.
Ph. Eur. Proposals for COC and COP
The proposed new general chapters provide specifications for COC / COP materials, used in the manufacture of containers for pharmaceutical use (for example prefillable syringes). They include requirements for extractable elemental impurities.
In the updated version for COC, an additional testing procedure for amides using Thin-layer chromatography (Ph. Eur. 2.2.27) has been introduced as alkanamides and alkenamides are listed as additives for the material.
According to the EDQM, stakeholders are encouraged to provide feedback only on this proposed test. Comments received when the text was published in Pharmeuropa 32.3 have already been evaluated by experts. The public deadline for comments is 31 March 2022.
More information can be found on the Pharmeuropa website.
Related GMP News
17.08.2026FDA announces new Draft Guidance on Container Closure Systems
29.07.2026Ph. Eur. Glass Containers
22.07.2026Recycled Packaging for Pharma?
22.07.2026Proposal for New Ph. Eur. Chapter on Prefillable Syringes
13.05.2026Proposed Revisions to USP's Glass Chapters
22.04.2026Roadmap for the Introduction of the Electronic Package Leaflet