A Pocket Guide to Laboratory CGMPs

Delphi Analytical Services, Inc. has spent years helping companies in the Pharmaceutical Industry improve their level of compliance with Current Good Manufacturing Practices (CGMPs). This involvement has included large and small companies who have already been subject to regulatory action from FDA as well as companies who are taking preventative measures to avoid regulatory action. As part of this effort, a significant amount of time has been spent reviewing the Quality Systems associated with analytical laboratories. This “pocket guide” is designed to provide an overview of the Quality Systems Based approach to Laboratory CGMPs. This is the same approach that FDA currently uses to evaluate if drug manufacturing facilities and laboratories are in compliance with 21 CFR 210 and 211. This guide is intended to be used as a quick reference or “sanity check” to insure that you are addressing the major issues associated with compliance within your laboratory. It also provides a list of resources where you may find additional help in bringing your laboratory up to the highest level of compliance with current good manufacturing practices. Soft cover booklet, 64 pages. Not available for download