GMP News: New Website about GMP-Non-Compliance Statements

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.

GMP News: New Website about GMP-Non-Compliance Statements