|Chicago Contract Manufacturing Organization Continues Standard of Excellence with FDA
|SUMMARY: Regis Technologies reports its most recent FDA audit of its cGMP manufacturing facility. The FDA found no observations (i.e. no Form 483), indicating a high level of compliance to Good Manufacturing Practices (GMPs) for chemicals and active pharmaceutical ingredients.
Morton Grove, IL August 25, 2016—Regis Technologies, Inc. reports that its most recent U.S. Food & Drug Administration (FDA) audit earned no objectionable findings, meaning no Form 483 observations were issued. This marks the third impeccable inspection in a row for Regis and demonstrates its commitment to a standard of excellence in quality and compliance.
The inspection was a routine Quality Systems inspection to support Regis’ FDA registration and ongoing manufacture of clinical and commercial active pharmaceutical ingredients (APIs). The 12 day inspection focused on Regis’ Quality and Production systems.
FDA investigators use Form 483 to record observations of non-compliance with the agency’s current Good Manufacturing Practices (cGMP) standards. Receiving no Form 483 observations is uncommon even in exemplary facilities. For example, in the 2015 fiscal year, the FDA inspected over 1744 drug facilities globally and issued Form 483 observations to 825 firms (48%). The data can be found on the FDA’s website.
Compliance with FDA standards is of upmost importance at Regis. Management enforces the importance of following Good Manufacturing Practices for both the safety of their staff and for the wellbeing of potential patients receiving drug products containing Regis-made active pharmaceutical ingredients. Regis is continuously looking to improve and uses internal audits, consultation, training, and even our customers audits to continuously prepare to meet the FDA’s and Regis’ own standard of excellence.
This sentiment is followed loyally by every member of the company. Their Quality Assurance department trains all personnel on safety, GMP, and Right-to-Know policies. Senior Quality Assurance Associate, Shellene Rodriguez, stated, “We would not be able to have three consecutive FDA inspections with no 483s without the hard work of each and every employee.”
In its 36,000 square foot facility near Chicago, Regis provides synthesis, separations, and manufacturing services to pharmaceutical and biotechnology companies. It works with customers to advance high value intermediates and active pharmaceutical ingredients (APIs) from initial process development and scale-up through final validation and commercial manufacturing. Regis offers pharmaceutical regulatory support services, as well as access to its proprietary innovative chromatography products and services. Regis’ advanced technologies are complemented by its deep expertise gained from 60 years of scientific excellence.
To learn more about Regis, visit its website at www.registech.com.
ABOUT REGIS TECHNOLOGIES: Regis Technologies, Inc. is a privately held company that provides cGMP synthesis and separations services to the pharmaceutical, biotechnology and other life science industries worldwide. Regis’ offerings include: analytical method development, process development, scale up, SFC preparative separations, validation and stability services toward the manufacture of complex custom synthetic products. In addition, Regis provides innovative chiral chromatography products and services.