June 2018 | VOLUME XVII | ISSUE # 4B
  From the COO's Desk
Within the last few weeks we have begun moving our laboratory operations into our brand new 30,000 ft. facility. This marks another chapter in the remarkable story of Q Laboratories. Those of you who have been clients for a long time have been part of the evolution of the company from a small regional laboratory to an internationally recognized leader in microbiology and analytical chemistry laboratory services. 
 David G. Goins, Chief Operations Officer
In April, the FDA released a Guidance Document, entitled, "Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs) - Questions and Answers - Guidance for Industry." The document is intended to "provide guidance regarding good manufacturing practice (GMP) for the manufacturing of APIs under an appropriate system for managing quality...and help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess."
Microorganisms present in pharmaceutical products or ingredients not only pose a threat to the user, but also may reduce or inactivate the therapeutic function of the product. To address this threat, USP Chapter <1111> - Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use, provides two tables of microbiological acceptance criteria. 
The FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality’s (OPQ) 2017 Annual Report provides a panoramic snapshot of the Pharmaceutical Industry and the regulatory and quality activities therein. Established in 2015, the OPQ consists of over 1,300 staff responsible for regulating the quality of human drugs marketed in the US, providing assessment, inspection, research, surveillance, and policy for product quality, facilities and manufacturing processes. 
Qlaboratories.com | office@qlaboratories.com | (513) 471-1300
1930 Radcliff Drive, Cincinnati, OH 45204-1823