GMP News - Packaging

The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

The USP posted a new timeline for the implementation of the plastics packaging chapters 661.1 and 661.2. So far, the new chapters were to become applicable on May 1, 2020. The implementation of the new requirements will now be delayed until December 1, 2025.

The FDA published a new guideline on the selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.

The "Glass meets Pharma" conference on glass packaging was held in early June in Berlin. Read more about the presentations and discussions at the first USP, EDQM and ECA Joint conference.

The US Food and Drug Administration (FDA) has defined in a guidance how medicinal products need to be labelled in the USA if their packaging is child-resistant. Read here what information is required for child-resistant packaging.

Together with project partners from industry and research & development, five associations have agreed on a testing method for evaluation of migration from paper and paperboard. Read more about the migration standard.