Kendrick Labs’ CGMP Services
As defined by the FDA: “CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.”
CGMP Biologics Stability and Release Testing
While mainly a contract research organization (CRO), Kendrick Labs also performs custom Stability and Release Testing of Protein Biologics according to CGMP regulations.
Typically, the first step is to perform a research feasibility test. Once feasibility is established, our team creates written protocols and specific SOPs for method validation. For example, a detailed sample preparation SOP is written for every new biologic being tested. Limits of detection and method precision are determined during the validation process. Criteria for acceptance or rejection of the test, and for acceptance or rejection of the product are established. The client reviews all documents; approval is required before work is initiated.
The QA team oversees all CGMP/CGLP projects. See our Accreditation page for more information about the team. Kendrick Labs’ Quality Manual is available on request. Our FDA registration is current through 2017 and we are subject to regular FDA inspection. Employees are trained in CGMP/CGLP procedures and the training is documented. SOPs are in place for all analytical methods including instrument calibration. A Rees Scientific system is in place for monitoring refrigerator and freezer temperatures. Key 1D and 2D SDS PAGE analysis methods have been validated in-house.
Note: that CGMP regulations are followed as much as possible for all pharma contract research. CGMP/GLP tracking records are available for research testing for an additional fee.
Call or email our Lab Manager, Jon Johansen (jon@kendricklabs.com, 800-462-3417) or Western Blot Manager, Matt Hoelter (matt@kendricklabs.com, 800-462-3417) to discuss your project and receive a price estimate without obligation.