Tuesday, 19 January 2021 14.00 - 15.30 h
Information about manufacturing sites that are out of GMP compliance is urgently needed. In a globalized world manufacturing is no longer located in the market where the medicinal products are sold. Complex manufacturing supply chains exist for both medicinal product and API manufacturing. Today, manufacturing steps take place in a long chain of production sites. Bulk manufacturing in site A, fill and finish in site B, primary packing in site C, secondary packaging in site D etc. And this example is an easy one - the reality is far more complex. The supervision of those sites is therefore of great importance for both authorities and pharmaceutical industry.
In the past only US FDA provided information about GMP non compliance by means of publishing Warning Letters on their website (see also the ECA Academy service of all GMP related Warning Letters). In addition the Freedom of Information Act allows to access more detailed information such as the Form 483 and the Establishment Inspection Report (EIR). Later the WHO has started to issue their reports about negative findings on the webpage. However the current list as per 5th March 2015 only counts two manufacturing sites - both located in India (Notice of Concern by WHO) Finally the EMA has established the EudraGMDP Database with GMP and GDP non compliance reports. Although EudraGMDP is already the most comprehensive service, there is still a long way to go. The database is not well designed and might not always work as needed. Moreover, not all EU Member States enter all their reports in the database in a timely manner. As per 5th March 2015 the EudraGMDP counted 77 sites with GMP non compliance reports and 2 with GDP non-compliance reports. An analysis of the companies listed in the database was published in January 2014. At that time 85 companies were listed with GMP Compliance Reports
Health Canada is the next authority which reacts on the need for information to identify companies and sites that do not meet GMP standards. On the recently published new webpage the agency informs about their non-compliance findings. On 27 February 2015 the "GMP Inspection Tracker" counted 15 manufacturing sites with serious GMP deviations. Again India takes a lead in this list. The country does not have an appropriate inspection system in place. Only a small number of the overall pharmaceutical manufacturing sites have been inspected by international authorities. But within this relative small number of sites (compared to the overall production in India) the number of GMP non compliant sites is enormous. Moreover, the findings are very critical and often sites have been found where even basic GMP standards have not been met. For example manufacturing data (batch records, analytical records) have been manipulated, production sites have been found in dirty conditions (even dead insects and mold have been found in clean rooms). The current list of 15 GMP non-compliant manufacturing sites counts 11 sites in India, 2 in Canada and 2 in China.