MicroProtein Technologies utilizes our innovative MPTxpress platform to produce recombinant proteins, enzymes, and plasmid DNA in accordance with current Good Manufacturing Practices (cGMP) to ensure that all products are manufactured in compliance with 21 CFR Parts 210 and 211.
Our Quality Systems are ISO 9001:2015 certified and managed by annual internal audits.
We are committed to delivering products that meet our customers needs and withstand regulatory scrutiny. MicroProtein’s bioprocessing facility, and equipment conform to the expectations that our clients require for FDA and worldwide regulatory compliance. Our quality assurance and management systems drive our approach to manufacturing that is specified in our Standard Operating Procedures (SOPs) and managed by our Quality Assurance group. Our SOPs detail our measures to comply with 21 CFR Parts 210 and 211, and cover training, documentation, deviations, corrective and preventive actions, quality control testing, equipment maintenance and calibration, environmental monitoring, materials management, product labeling and distribution, batch record management, and product processing.
Quality begins with our staff of experts in MPTxpress technology, other bioprocessing innovations, quality control, and up-and downstream manufacturing. We are committed to a culture of continuous learning and training.
Microprotein’s facilities are carefully designed and maintained to prevent process contamination and adhere to requirements for purity and potency. The facility is zoned into controlled and non-controlled areas to segregate work activities. Our facilities are adequately sized and designed to handle optimal workflows and equipped with controls to mitigate contamination, cross contamination, and segregation of materials and products. Environmental monitoring is performed to track conditions and trends that may potentially impact product quality.
Our calibration plan details our approach to maintaining our equipment in accordance with cGMP requirements. Equipment is classified, validated, calibrated, and maintained in accordance with its intended use and impact on manufacturing. The Quality Assurance department maintains a list of all relevant equipment along with tracking the frequency of services and due dates.