Symbiosis Successfully Completes MHRA Audit Inspection

Scottish contract development and manufacturing organization (CDMO), Symbiosis, has successfully completed a scheduled inspection by the Medicines and Healthcare products Regulatory Agency (MHRA).

According to a Sept. 29, 2020 press release, the company, which specializes in the sterile manufacture of vaccines, pharmaceuticals, and biopharmaceuticals for clinical and commercial use, recorded no critical or major observations by MHRA. As a result of the successful outcome, Symbiosis has extended its MHRA regulatory licenses for the good manufacturing practice (GMP) sterile manufacture of investigational medicinal products for clinical trials and the manufacture of aseptically-filled licensed niche commercial products. Additionally, the inspection was completed by remote inspection to comply with COVID-19 pandemic response guidelines for the United Kingdom.

“The whole Symbiosis team is pleased with the successful outcome of this regulatory inspection, performed remotely in line with COVID-19 pandemic response guidelines,” said Colin MacKay, CEO at Symbiosis, in the press release. “Quality is a fundamental part of our business ethos and this reinspection success is a positive reflection of the caliber and investment in our quality system and the recruitment of highly skilled and experienced colleagues to ensure that we remain a market leader and provide the highest quality and compliance standards to our clients.”