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What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of the questions in conjunction with the "Certification by a Qualified Person and Batch Release" being now answered by an inspectorate.
On 15 March 2017, a common press release was published to announce the joining of Pro Generika e.V. as shareholder in the ACS PharmaProtect GmbH (ACS). ACS was founded in 2012 with the aim of developing and operating the manufacturer database in Germany. Read more about the joining of Pro Generika e.V. in the ACS PharmaProtect GmbH.
The British inspectorate MHRA has recently published a comprehensive document that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept must be applied. One essential element of that concept is EMA's Q&A Paper describing when a product should be classified as highly active. This Question & Answer Paper can be commented on until the end of April 2017. Read more here.