A laboratory inspection reveals instances of non-compliance to GMPs
Bastien Cany | 9 January 2014 |
The Marette laboratory is based at the premises of this pharmacy in Courseulles-sur-mer (c) Pyc.
The health and safety decision regarding the Marette laboratory describes a number of deviations from the provisions of guideline 1 of the Good Manufacturing Practices governing the pharmaceutical industry.
Following further investigations at the beginning of the week, the Agence nationale de sécurité des produits pharmaceutiques (the French safety agency for pharmaceutical products or ANSM) eventually suspended activities relating to compounding and hospital preparations at the Marette pharmacy in Courseulles-sur-mer in Calvados. This decision was also based on confirmation of microbial contamination in parenteral nutrition bags produced by this establishment and implicated in the death of three newborn babies at Chambéry hospital last month. For the first time, the ANSM has clearly highlighted the laboratory’s failure to comply with certain provisions of Good Manufacturing Practices governing the pharmaceutical industry.
These failings specifically relate to guideline 1 of the GMPs for sterile medicines. The text specifies that the establishment “does not guarantee complete management of the contamination risks for items produced”. Inspectors revealed instances of non-compliance in terms of disinfecting of hands before handling substances, checking gloves after critical processes and the management of environmental anomalies and entries and exits to the controlled atmosphere area.
However, no direct link has been established between these instances and the causes of the contamination. Only one germ has been detected in the bags that have been analysed. It is a new type of enterobacterium that has not yet been named, similar to Ewingella and Rahnella. Furthermore, the results have highlighted a particularly high endotoxic load. For now, the Ministry of Health and the ANSM have not given any details about the type of aseptic equipment used by the company such as clean rooms, insulators, biosafety cabinets etc. As the source of this contamination is still unknown, detailed investigations continue into the whole supply chain, from production to delivery.
Source : www.processpropre.fr