GMP News - Packaging


USP Published New Drafts for General Chapters on Plastic Materials

In the current issue of the Pharmacopeial Forum, the USP general chapters on plastic packaging materials have been re-published for comment.



Brexit: Safety Features & Multi-Country Packs

Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published  the answer to this and other related questions.



US Track and Trace System

The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.



Safety Features: Handling of Alerts

The safety feature provisions enetered into force - How to report a falsified pack?



Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.



New ISO Standard for Tamper-Evident Packaging

The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".



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.



ISO standard for packaging machines

A new international technical committee ISO/TC 313 Packaging Machinery has been founded, which will be responsible for establishing international standards for packaging equipment and systems.



New Timeline for USP Plastics Packaging Chapters

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.



New defect Evaluation List for Moulded Glass out now

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Moulded Glass which includes an appendix with example pictures of specific defect characteristics is out now.



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".



Successful ECA, USP and EDQM Joint Conference on Glass packaging

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.


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