BioPharma Services Inc. has announced that its Toronto-based clinical and bioanalytical site for Phase I/IIa clinical trials and bioequivalence studies has successfully completed an audit by the U.S. Food and Drug Administration (FDA). This was BioPharma’s 4th inspection by the FDA (2008, 2009, 2012 and 2015) and the 1st inspection of the bioanalytical laboratory unit. The audit was conducted from June 1st to June 5th as a Pre-Approval Inspection for ANDAs submitted. The inspection confirmed that the clinical and bioanalytical facilities were in compliance with the principles and guidelines of GCP. No Form 483 observations were issued. This is BioPharma’s 3rd consecutive FDA inspection without Form 483 observations.
The successful outcome of the audit is the result of BioPharma’s unswerving commitment to the highest quality standards. It is supported by a growing list of additional regulatory inspections, including GCP inspections by the UK MHRA (2010, 2013) and, more recently, an OECD GLP Certification by the Standards Council of Canada in February, 2015. This recent FDA audit is another milestone achievement for BioPharma.
“I am thrilled and proud of our people and company for achieving a flawless FDA inspection and for maintaining top notch quality in our bioanalytical lab and clinics. Great quality is good business and our team continues to excel on both fronts,” remarked Mr. Renzo DiCarlo, CEO of BioPharma Services.