New FDA Guidance for COVID-19 Packaging Changes: Glass Vials and Stoppers
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.
Track & Trace: Do Medicinal Products have to be Decommissioned when Distributed to the UK?
Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.
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.
Labelling and Packaging Flexibilities for Covid-19 Vaccines
To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.
New USP Draft Chapter on Plastic Components Used in Manufacturing
In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.
Extractable Elements in Plastic Materials - Extended Deadline for Comments
The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.
Update on COC / COP and Extractable Elements in Plastic Materials
Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.
Version 17 of the Q&As on Safety Features for Track & Trace
The European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".
Update on the Implementation of USP´s revised Plastic Packaging Chapters
The United States Pharmacopeia recently posted an update on the delayed implementation of General Chapters <661.1> and <661.2> together with information on the revision of General Chapter <661>.
USP Proposes New General Chapter <668> Cured Silicone Elastomers
The USP General Chapters—Packaging and Distribution Expert Committee is proposing a new general chapter <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components.