This quarter we have extended our services to the Middle East welcoming a new distribution company in Lebanon which requires our support with the upgrade of their facility and quality system and to make these compatible with the European Good Distribution Practices (GDP) regulations. Such upgrading will include all the classical GDP-issues like facility lay-out and product routing, appropriate Standard Operating Procedures to cover all the essential processes, training and qualification of employees and last but not least; temperature control of the warehouse. It is planned to finalize this project in the first quarter of 2011 enabling one of the major suppliers to audit the upgraded facility shortly afterwards.
More “foreign stuff” this quarter refers to a Factory Acceptance Test (FAT) we performed in Italy. This FAT involved an isolator for the production of an intravenous radiopharmaceutical. Such isolators heavily rely on automotive systems as the handling of radioactive materials requires appropriate shielding of the operator. Three more colleagues went to the UK for various different reasons. One performed an audit of a quality control laboratory on behalf of one of our clients, one gave a pharmacovigilance training to a newly installed sales team and one witnessed a European Regulatory Affairs (ERA) meeting of one of our major clients, a global Top-10 pharmaceutical company. These combined foreign activities reflect the growing international exposure of our company.
But that does not mean we can reduce, let alone ignore, our domestic activities in the Netherlands. Such “domestic” projects included the design of a new manufacturing laboratory for phytopharmaceuticals, the application for a narcotics license to enable the marketing of a newly developed opioid, as well as the take over of the regulatory affairs management of the complete portfolio of an OTC company. Also, an unusual accumulation of GDP projects occurred this quarter with not less than 4 distribution companies requiring our support with the wholesale license application process. Such support may vary from a single GDP-course to instruct operators, to the complete responsibility for quality manual, training, warehouse mapping and RP (Responsible Person) responsibilities.