FDA's CFSAN LABORATORY QUALITY ASSURANCE MANUAL (LQM) 3rd Edition (2009) is now available on-line. Having an electronic version should increase the ease of distribution and use of the manual. It is in PDF format and represents the current official version. The LQM establishes the policies and instructions related to laboratory quality assurance in CFSAN. In addition to complying with FDA Staff Manual 2020, Quality System Framework for Internal Activities, the manual is a central resource for understanding CFSAN’s quality system and provides guidance on quality concepts principles, and practices. The LQM also provides Center staff with the fundamental information to implement basic quality concepts, principles, and practices throughout CFSAN laboratories. This manual serves as a key element in the implementation of a Quality Management System. The target audience for this manual includes Center Laboratory Supervisors (Office Directors, Division Directors, Branch Chief, Team Leaders, and other supervisors, including Acting Supervisors), laboratory researchers, and other key laboratory personnel.
- CFSAN LABORATORY QUALITY ASSURANCE MANUAL 3rd Edition (available in PDF, 1.01 Mb)