[Stability Testing related News – vol.8]

◆　New USP Draft on Plastic Materials（30-Oct-13　ECA）

In a draft for a new General Chapter on “Plastic Materials”, the USP has described the requirements set today on plastic packaging materials. It has also defined when plastic materials are suitable for use as packaging systems for medicinal products.

◆　Questions and Answers on Design Space Verification（30-Oct-13　FDA,EMA）

The Q&A is a reflection of EMA’s and FDA’s position on the topic of design space verification. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/11/WC500153784.pdf

◆　News from the US on particles in injectables（06-Nov-13　ECA）

Particles in medicinal products for parenteral use as well as the 100% inspection on particles stay in the focus of the US American authorities. The upcoming new monograph <790> “Visible Particulates in Injections” could finally provide a good definition. In the draft, USP defines “essentially free” as a batch of parenteral product that has been 100% inspected, meeting an AQL of 0.65% or tighter. It is aimed to officially publish the new monograph in USP37-NF32, mid of 2014. It will be interesting to see, if the European Pharmacopeia will also get more precise.

◆　Revision of the EU GMP Guide: EU Commission Publishes Comments for Chapters 3, 5, 6 and 8（20-Nov-13　ECA）

The EU Commission published the responses to the public consultation of 4 revised chapters of the EU GMP Guide. Paragraph 6 of Chapter 3 Premise and Equipment has been revised and extended. It contains regulations on how to avoid cross-contamination. The revisions made in Chapter 5 Production can be found in the paragraphs 26 to 28. Now, the drug manufacturer must also ensure that all the starting materials used originate from controlled sources. Moreover, there are new requirements now with regard to the control of starting materials and the obligation to inform authorities when a medicinal product is no longer available for GMP reasons. Chapter 6 Quality Control now provides new requirements on the transfer of analytical methods as well as new regulations about the handling of out-of-specification results. Chapter 8 Complaints and Product Recall points out – among other things – the significance of a quality management system for the evaluation of quality defects in relation to product recalls and likewise clarifies the requirements regarding the reporting (when and how) of quality defects to the authority.