GMP News - Packaging

21.04.21

Track & Trace: Amendment of the Delegated Regulation on Safety Features

On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.

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07.04.21

Revised Ph. Eur. Chapter 3.2.9. Rubber Closures

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.

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07.04.21

Supplier Qualification for Packaging Material

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications.

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11.03.21

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.

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27.01.21

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.

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27.01.21

Revision of USP <661.1> Plastic Materials

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.

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16.12.20

Avoiding Non-Compliance in Packaging Areas

Filling product into open containers with leaks above the packaging lines? Not a good idea - A current FDA Warning Letter provides information.

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04.11.20

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.

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14.10.20

GMP Deficiencies in Packaging

A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

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09.09.20

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.

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19.08.20

Can the Application of Safety Features be outsourced?

Safety features may be applied by external manufacturers and suppliers. This has now been clarified in a Question and Answer document.

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07.07.20

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.

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20.05.20

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.

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22.04.20

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".

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26.02.20

GMP for Sterile Packaging Components

Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?

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