GMP News - Packaging

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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22.01.20

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>.

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22.01.20

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.

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20.11.19

Nitrosamines in Elastomers?

An USP Stimuli article on Elastomeric Components for Inhalation Packaging / Delivery Systems has been published in Pharmacopeial Forum, proposing to test for nitrosamines in elastomeric components used for inhalation products.

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30.10.19

Updated Ph. Eur. Chapter on plastic containers

A revision of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa.

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16.10.19

Version 16 of the Q&As on Safety Features for Track & Trace

The just published Version 16 of the Q&A´s on Safety Features puts a strong focus on Q&As addressing false alerts due to incorrect scanning by end-users.

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16.10.19

Ph. Eur. 2.4.20. Determination of elemental impurities

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.

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02.10.19

Track & Trace: EMVO stakeholders call for inspections

Seven months into the operational phase a significant number of manufacturers and supply chain actors have not yet connected to the EU verification system. Now, the EMVO stakeholders encourage the NCAs to undertake inspections on all supply chain actors.

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18.09.19

New FDA guidance on Child-Resistant Packaging

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.

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11.09.19

Track & Trace: Still ongoing issues

It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.

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04.09.19

USP Packaging Standards

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

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28.08.19

New Defect Evaluation List for Rubber Parts

The brand new and completely revised and enlarged 2019 edition of the Defect Evaluation List for Rubber Parts has been published.

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