GMP News - Packaging

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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07.08.19

Version 15 of the Q&As on Safety Features

The European Commission published version 15 of the Q&A´s on Safety features for medicinal products for human use. The new version includes a revision of the Q&A on safety features relating to IMPs.

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24.07.19

Safety Features - how is it progressing?

The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.

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24.07.19

Defect Catalog for Films and Foils

A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.

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17.07.19

Track & Trace in Russia - One More Standard in Place?

The introduction of a Europe-wide serialization system (often simplified to "Track & Trace") has brought great challenges to pharmaceutical manufacturing companies. In addition, many countries outside Europe are preparing serialization systems. Internationally speaking, Russia is already very far advanced. Read more about the new requirements for Track&Trace in Russia.

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17.07.19

Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

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17.07.19

New structure of Ph. Eur.´s packaging section

The numbering of the Ph. Eur. packaging section 3 has been changed for the 10th Edition following the creation of the new chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

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