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UFAG Laboratorien AG announces a successful outcome of a two day site inspection at Sursee from a Food & Drug Administration Inspector. The inspection was initiated as a pre approval inspection (PAI) for a pharmaceutical product application for the US market. UFAG Laboratorien AG as an analytical service provider supported the applicant by performing elemental analyses (ICP-OES). In addition to the PAI aspects all general GMP aspects of UFAG’s quality system have been inspected in detail during the second week of March 2012. The inspection by the US FDA resulted in no FDA 483 observations.
A wide range of data including but not limited to, method transfer and validation, microbiology, raw material and finished product testing, stability testing and storage, equipment qualification and maintenance, computer system validation, OOS investigations, change control, CAPA, training records were reviewed and found to be in compliance to cGMP. The inspection was the second FDA inspection of UFAG Laboratorien AG after 2006, and was accompanied by Swissmedic represented by the „Regionales Heilmittelinspektorat Nordwestschweiz“ (RHI).
UFAGs commitment to quality and its efforts to ensure the highest level of client support is confirmed by the successful result.To the summary