Regulatory Compliance Management Philosophy
Pacific BioLabs operates (and has been operating since 1982) a Quality System designed to achieve compliance with the Current Good Manufacturing Practices (cGMPs) at a minimum. In other words, PBL uses the quality requirements for drug manufacture 21CFR210, 211 and 610 as the backbone of our regulatory practices.
In addition, we overlay Good Laboratory Practices (GLP, e.g., 21CFR58 or 40CFR160) on top of the basic cGMP requirements when a customer needs that extra assurance. Our quality systems utilize a matrix of requirements similar to those in the medical device Quality System Regulation (QSR-21CFR820) to provide confidence to all of our customers that their needs are met.