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In Pharmeuropa 29.2 several drafts of general chapters regarding packaging components and materials made of PVC have been published for comment. Read more about the drafts on materials and containers based on plasticised poly(vinyl chloride).
Reverse osmosis as a main barrier to all types of impurities plays an essential role in both the production of Purified Water (PW) and cold WFI production. In the pharmaceutical industry, this module has to be heat sanitisable. Now the question is how often heat sanitisation has to be performed?
The USP Expert Committee Packaging and Distribution decided to provide a three-year period for implementation of the requirements specified in General Chapters <661.1> and <661.2>. Read more about the revison regarding USP General Chapters Plastic Materials of Construction and Plastic Packaging Systems for Pharmaceutical Use.
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would decrease now because of the recognition of EU inspections. Read more about the consequences of the GMP Inspection Agreement.
Hoses are more often used than one thinks. On the one hand they are used in routine operations, on the other hand they can also be utilised as interim solution before a new pipe is drawn. They then fall into the first case situation. While one pays more consideration to pipes, their material quality and surfaces, hoses are often neglected. But what about requirements for hoses? Are there any?