Pacific BioLabs and all of its medical device and pharmaceutical clients are required to operate in accordance with cGMP (current Good Manufacturing Practices) regulations. Pacific BioLabs is committed to perform all testing in accordance with our understanding of the cGMPs. A comprehensive body of standard operating procedures covers all aspects of our laboratory operations. We are routinely inspected by the FDA and auditors from many of our clients.
Pacific BioLabs does not assume any responsibility for the appropriateness and/or regulatory acceptance of any client’s testing program. It is the responsibility of each client to assess the testing and test validation requirements of their products and quality control systems. Our staff will endeavor to alert clients of testing programs that may need further consideration to determine conformance to cGMPs.
For most product safety submissions, the FDA and EPA require that testing be performed in accordance with GLP (Good Laboratory Practice) regulations. It is the client’s responsibility to determine when GLP treatment is required and to inform Pacific BioLabs in writing of this requirement at the time of sample submission. Pacific BioLabs will perform testing in accordance with GLPs when requested by the client. (There is an additional charge for GLP treatment.)