Tuesday, 13 June 2023 13.00 - 17.45 h
The EuropeanComplianceAcademy developed a so-called Good Practice Guide some years ago. It is a juxtaposition containing the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001.
Now, version 10 of this GMP matrix is available. The actual GMP Matrix confronting the three regulations has 21 pages. The matrix shows the requirements laid down for a given topic (such as cleaning or monitoring) in the respective regulation. The GMP Matrix is completed by the three regulations having further 530 pages. Despite the size of the reference book it is nevertheless composed in such a way it can easily be taken along for audits. That's why an ever increasing number of companies provides its auditors and quality assurance department personnel with the GMP Matrix.
It can be purchased at the European Compliance Academy. The price is € 99 for ECA members and €149 for non ECA members.