On April 14th 2016 U.S. Food and Drug Administration published a draft guidance for comments on Data Integrity: Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry. The draft guidance is a question & answer document, raising 18 questions regarding data integrity and provides FDA’s current thinking about the role of data integrity in current good manufacturing practice (CGMP) for drugs,…Read more
The European Commission has prepared the revision of Annex 16 to the EU Guidelines for Good Manufacturing Practice for Medicinal Products „Certification by a Qualified Person and Batch Release“.
Coming into operation as of 15th April 2016, every GMP expert should be informed what matters in the new Annex 16.…
A couple of years ago I received an emergency call from one of our clients: “Hey Thomas, I just got a message from IT who told me that they will no longer support our current IT infrastructure for MES!…Read more