Laboratory Control System Operations in a GMP Environment. David M. Bliesner

Drug Enforcement Agency (DEA) scheduled materials (e.g. methamphetamine, methadone, etc.). 2.6.13 Does the Reference Standard SOP address (map) proper handling of controlled substance reference standards?

Tools and Templates

The following are provided in electronic format as Example Tools and Templates, which can be found in the Chapter 2 Appendix (www.wiley.com/go/Bliesner/LabControl_GMPEnvironment):

       Checklist for Evaluating the Laboratory Managerial and Administrative Systems Sub Element

       Example-Template Job Description

       Example-Template Work Flow Diagram

       An Example Listing of Quality Compliance and Operational Laboratory Metrics

Reference

      1 1 US FDA (2013). Warning Letter WL: 320-13-12, 25 March 2013.