stevenl schreef:
[quote=Fixed]
July 13, 2007 · Pharming Facilities Obtain GMP Status ... [ NL versie ]
Biotech company Pharming Group NV (“Pharming” or “the Company”) (Euronext: PHARM) announced today that its facilities for the manufacturing of Rhucin® have successfully passed all inspections conducted by the European Medicines Evaluation Agency (“EMEA”) establishing that they comply to the standards of Good Manufacturing Practice (“GMP”) for pharmaceutical production.
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Inspecties zijn wat betreft processes en facilities. Het zegt niets over het product zelf.
Zie beneden:
The EMEA has confirmed that all facilities and processes that are involved in the manufacturing of Rhucin®, Pharming’s lead product, operate according to GMP standards. These facilities include Pharming’s facilities for transgenic rabbits, the external facilities where milk and product are stored and processed and the Company’s headquarters in Leiden as far as it is concerned with quality aspects of Rhucin®.