Olga Ganz, one of PACT’s two cell manufacturing specialists, has recently completed the necessary qualifications for the American Society for Quality, Certified Pharmaceutical GMP Professional (CPGP). A CPGP understands the good manufacturing practices (GMP) as regulated and guided by national and international agencies for the pharmaceutical industry.
Since its inception, PACT has followed the stringent protocols necessary to achieve GMP compliance for all aspects of the manufacturing process including regulatory governance, record management systems, storage procedures, sterile manufacturing systems, and product design factors.
Ganz was part of the approximately 49 percent of applicants to pass the ASQ certification examination, which was administered over four and a half hours and included 165 questions that measure comprehension of Pharmaceutical GMP Professional “body of knowledge”.
In addition to GMP compliance, Ganz’s certification is the most recent step in PACT’s strategic plan to meet the Foundation for the Accreditation of Cellular Therapy (FACT) standards. Olga Ganz will fulfill specific quality control management functions independent of manufacturing responsibilities.
“From the perspective of a director of operations, Olga Ganz has escalated PACT’s evolution regarding our commitment to regulatory compliance and process of continuous quality improvements.”