Quality & Regulatory Systems

Our cGMP manufacturing facility has been qualified according to ISO 14644, Clean Rooms and Associated Controlled Environments as called out in Volume 4, EU GMP Guidelines, Annex 1: Manufacture of Sterile Medicinal Products, with re-qualification of the facility every six months. The facility was designed based upon the output of risk analysis as per ISO 14971, Application of Risk Management to Medical Devices.

Our Quality Management System is certified to ISO 13485:2003, Quality Management Systems – Requirements for Regulatory Purposes. Regularly scheduled surveillance audits by our certifying authority ensure continued adherence to this standard. Under the standard, we must demonstrate not only the dedication of senior management to cGMP standards, but also our commitment to provide quality product using the best available materials and methods.

Since the commencement of operations of our manufacturing facility in the second quarter of 2009, we have successfully passed numerous audits by current and prospective distribution partners and pharmaceutical, regenerative medicine, and contract manufacturing customers.

Customer feedback is a vital part of our continuous quality improvement process. Our Case Management System is designed to quickly respond to customer requests and track trends to improve processes and provide input to corrective and preventive actions. We combine this valuable input with our own internal audit findings to continually improve our quality environment.

To assist customers with their regulatory marketing applications, Master Files for BioLife products are on file with the FDA. To request a cross reference to our Master Files, please complete our convenient request form.