GMP News - Packaging

The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.

USP´s General Chapters–Packaging and Distribution Expert Committee (GCPD EC) proposes to replace spectral transmission with spectral absorbance for amber glass containers based upon wall thickness.

A general revision of Ph. Eur. Chapter 3.2.9 "Rubber Closures" has been proposed in Pharmeuropa 33.2. In particular the proposal includes changes to the sections regarding composition changes and extractable elements, functionality & fragmentation testing.

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.