New Ph. Eur. Structure of Chapter 3 on Materials and Containers
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.
Single-Dose, Multiple-Dose or Single-Patient-Use Container?
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.
Ph. Eur. Draft on Depyrogenation of Packaging Materials
The EDQM published a draft for a new Ph. Eur. general chapter regarding pyrogen inactivation or removal from primary packaging materials and equipment. Read more about depyrogenation of items used in the production of parenteral preparations.
Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging
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.
CMDh Clarifications on the Implementation of the Falsified Medicines Directive
In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".
New suggestions by the USP on chapter <659> have been published in the Pharmacopeial Forum (PF) 44 (4). It addresses plastic packaging as well as the regulations and requirements for child-resistant packaging. Read more about chapter <659> - Packaging and Storage Requirements in this article.
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.
New USP Chapter on Moisture Barrier of Plastic Packaging Systems
The USP published a draft of a new general chapter on the Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems. Additionally the general chapter Containers—Performance Testing <671> has been revised and published for comment in the same issue of PF.
Packaging materials: DIN standard on migration published
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.