GMP News - Packaging

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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03.07.19

Serialisation: New Guidance for EU Inspectors

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

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26.06.19

Warning Letter for US Pharmaceutical Manufacturer: Container/Closure Issues and Other Deficiencies

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.

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12.06.19

Revised USP Elastomeric Components Chapters

The previous draft chapters were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee has published new proposals on elastomeric components.

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08.05.19

Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

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17.04.19

GMP for Sterile Containers

Following the Q&As on what data is required for sterilization processes of primary packaging materials published in 2016, the EMA recently released the new Guideline on the sterilization of the medicinal product, active substance, excipient and primary container.

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10.04.19

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.

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26.02.19

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.

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26.02.19

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.

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13.02.19

Safety Features: Handling of Alerts

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

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