Serious GMP Violations might bring 14 Employees of a New England Compounding Center to Jail

The US department of Justice has indicted 14 people connected with the New England Compounding Center (NECC). The company has been accused of manufacturing substandard products which do not comply with the GMP regulation. Read more about the case in our GMP News.


EMA publishes several GMP Non Compliance Reports

The European Database on GMP and GDP Inspections (EudraGMDP) provides a read-only access for industry. The database is a very useful tool to monitor compliance of suppliers and contract partners. It also contains information about inspection findings. Read more about the latest entries to EudraGMDP.


FDA increases Number of unannounced Inspections

Up to now, the US Food & Drug Administration (FDA) only increased the number of inspections in the USA. Now, the authority also increases the number of unannounced inspections abroad.  Read more here.


Guideline "ICH Q3D - Elemental Impurities" published as Step 4 Document!

More than one year after the publication of the ICH Q3D Guideline on "Elemental Impurities" as "Draft Consensus Guideline" (Step 2B document), the final Guideline has now been released. Compared to the draft of 2013 the main changes relate to the limits of the daily absorption of metallic impurities in the different dosage forms. Read more here.


ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.


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