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

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2.6.4 Are all standards labeled with name, source, lot number, and expiration date? 2.6.5 Do written procedures include provisions for prevention of contamination of primary standards? 2.6.6 Are standards stored in a secured area under environmentally controlled and monitored conditions? 2.6.7 Are procedures for assuring standard integrity available? 2.6.8 Are working or “house” standards checked against primary standards at appropriate intervals? 2.6.9 Are stock solutions appropriately identified, and is their expiration based on their true stability? 2.6.10 Do procedures exist for the certification and use of non-commercially available reference standards? 2.6.11 Do certificates of analysis exist for all reference standards and are these certificates stored as controlled documents? 2.6.12 Have provisions been made for handling, controlled substance reference standards? This refers to 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.

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