(PRWEB) November 23, 2012
Next Breath, LLC, a Contract Research Organization (CRO) with expertise in analytical testing of pulmonary and nasal drug delivery systems, announced that the US Food and Drug Administration (FDA) completed a GMP inspection of Next Breath’s laboratory facility in Baltimore, Maryland. The inspection found the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP). The US FDA authorities inspected the facility on October 15th, 2012 with an emphasis on commercial batch release.
The entire facility including its quality system geared at contract research and commercial batch release of drug products were subject to a detailed compliance inspection. At the completion of the inspection, no Form 483 and no observations were issued. This follows a successful accreditation of World Health Organization (WHO) for Next Breath as a testing facility for nasal spray vaccine drug delivery earlier this year adding to our overall compliance to US and international quality standards.
Julie Suman, President, “We are very pleased with the results of the US FDA GMP inspection, which confirms Next Breath’s commitment to meeting and exceeding the highest quality standards. We work diligently to maintain regulatory standards and we have once again demonstrated our ability to sustain and continuously improve quality systems within our organization.”
About Next Breath
Next Breath, a member of the AptarGroup, is a cGMP contract services organization for pharmaceutical, biotech and medical device companies that bring inhalation and nasal products to market. Next Breath provides comprehensive solutions to the development processes for oral, inhaled, and nasal drug products. Our in vitro services range from pre-clinical formulation development to analytical testing in support of submissions to regulatory agencies. Next Breath has led successful submissions for pulmonary and nasal drug products and devices in the US and international markets.