By United Nations
Deals assistance for the implementation of a high quality administration approach in drug checking out laboratories: a dedication to caliber and non-stop development.
Read or Download Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories: A Commitment to Quality and Continuous Improvement (United Nations Office at Vienna) PDF
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Extra info for Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories: A Commitment to Quality and Continuous Improvement (United Nations Office at Vienna)
If the items are not homo geneous, they must first be separated into homogeneous groups and an appropriate sampling plan then devised for each group. The sampling plan may have a non-statistical basis (for example, a management or judicial directive) or statistical basis (for example, hypergeometric or Bayesian), but should be practical and easy to carry out by non-scientists, avoid unnecessary additional work for the laboratory, be easy to explain and be defensible in court. Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories 27 The laboratory should provide guidelines to ensure that the materials to be tested are properly sampled, labelled, packaged, preserved and stored before submission to the laboratory.
Subsequent submissions related to the same case should be clearly identified as such using the same unique case number. At the laboratory, an authorized person should receive and carefully check the samples and documents. One or more identified individuals should also be authorized to reject partially or wholly submissions that do not accord with the laboratory’s acceptance policies. They should inform the laboratory manager of any such rejections. Any remedial action taken should always be documented.
Lot/ batch numbers of standards and critical reagents should be recorded and they should be tested for their reliability. Standards and reagents should be labeled with: "" Name; "" Concentration, where appropriate; "" Preparation date and/or expiry date; "" Identity of preparer; "" Storage conditions, if relevant; "" Hazard warning, where necessary. The laboratory should have a reagent solution preparation register that is kept in a suitable location. When a reagent solution is prepared, the person responsible for the preparation should record in that register the date, the ingredient weights and volumes actually used and his or her signature.