GMP News - Packaging

The USP has recently published a revision of its Chapter <87> "Biological Reactivitiy Tests, In Vitro" for comments. One of the objectives is a better alignment with other relevant USP chapters.

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

Due to the current shortages of glass vials the USP is announcing a proposal to modify General Chapter <660> Container— Glass. In particular, the revision is anticipated to remove the glass classifications based on composition.

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.

The USP General Chapters—Packaging and Distribution Expert Committee is proposing a revision to the Scope section of chapter <661> Plastic Packaging Systems and Their Materials of Construction. The revision is published to clarify the testing expectations that are outlined in <661.1> and <661.2>.

The final version of Ph. Eur. 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders has been published in the European Pharmacopoeia (Ph. Eur.) 11.1. The supplement is now available and will become applicable as of 1 April 2023.

Due to a change in REACH, the Ph. Eur. is considering to replace the plasticiser DEHP and is therefore seeking information from manufacturers. The deadline for replies is 30 September 2022.