GMP News - Packaging

01.07.15

Track&Trace - IT Implementation ordered by European Pharmaceutical Associations

The "European Medicines Verification Organisation" (EMVO) has developed a model for the practical and cost effective implementation of the system for data storing and has also signed framework agreements with three partners. Find out more about the EMVO model.

10.06.15

USP Chapter <1207>: Container Closure Integrity Testing

The USP Chapter <1207> on the integrity testing of primary containers of sterile dosage forms is currently in the second round of review. Its adoption is expected for this year. Find out more about USP Chapter <1207>.

03.06.15

Optimized Method for determining the Water Vapour Permeability for Packaging - new USP Proposal

A USP article published in the Pharmacopoeia Forum discusses an improved method for the determination of the water vapour permeability in packaging for solid dosage forms such as tablets or capsules. Find out more about the optimization of the water vapour permeability test for packing materials.

27.05.15

New USP Chapter on the Integrity of Pharmaceutical Packaging

The USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum. New proposals about the content have been published - now in form of 4 general chapters on the integrity of packaging materials. Find out more about the new USP Chapters on the Integrity of Pharmaceutical Packaging.

06.05.15

Warning letter due to insufficient container-/closure integrity

A site of the company Hospira in Italy received an FDA Warning Letter at the end of March which criticises among others defects concerning the closure of vials and the related possible microbiological contaminations. Read more about the Warning Letter.

29.04.15

Update of the USP Requirements for Packaging Materials made of Plastics

In the Pharmacopeial Forum the USP has described the future requirements for packaging materials made of plastics. The original proposals were now revised, and new proposals were published with regard to the structure and content of the General Chapters on packaging materials made of plastics. For more information please see the Update of the USP Requirements.

18.03.15

BS EN 16679 for the Review of Manipulations on Medicinal Product Packaging issued

The completely new created norm BS EN 16679 has now been available at British Standards since December 2014. It is supposed to support the use and implementation of the EU Counterfeit Directive. Read more about the BS EN 16679 for the Review of Manipulations on Medicinal Product Packaging.

28.01.15

Leakages in Ampoules cause Recalls

There have been several recalls of sterile ampoules in Switzerland. The manufacturer stated a possible leakage as reason for the recall. Read more.

10.12.14

Corrigendum of the EU Counterfeit Directive

In the Official Journal of the European Union from 9 August 2014, two corrigenda to the counterfeit directive have been published with regard to the prevention of the entry into the legal supply chain of falsified medicinal products. Please read more details here in this News.

12.11.14

New USP Requirements on Plastic Packaging Systems

The USP describes in an article of the Pharmacopeial Forum the future requirements for plastic packaging systems. Here, the importance is laid on the selection of suitable, safe plastic materials and the verification of potential interactions. More information can be found here in the News.

20.08.14

What does the FDA say regarding glass delamination prevention?

Delamination is a phenomenon that can occur repeatedly in glass containers. The glass particles emitted into the solution can pose a risk especially for parenteral drugs. Read the current view of the FDA on this topic.

30.04.14

Pharmaceutical Packaging - New USP Proposal for Optimised Method of Measuring Moisture Vapour Permeation

An improved method of measuring water vapour permeation for solid oral dosage forms like tablets or capsules has been discussed during a USP - PQRI Workshop and presented in the Pharmacopeial Forum. See the detailed information.

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