GMP News - Packaging

A revision of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa.

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

The European Commission published version 15 of the Q&A´s on Safety features for medicinal products for human use. The new version includes a revision of the Q&A on safety features relating to IMPs.

A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.