Guidance for the Implementation of a Quality Management by United Nations

By United Nations

Bargains assistance for the implementation of a top quality administration procedure in drug checking out laboratories: a dedication to caliber and non-stop development.

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Extra resources 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)

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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. This information is needed to trace possible sources of error in an analysis. Assigning each batch of reagent with a unique identifying number can be helpful in this respect. Reference standards, working standards, in-house reference standards, reagents and other materials should be correctly stored to ensure their stability and integrity.

In the absence of CRMs, commercial reference standards should be used. These commercial reference standards are supplied with a description of their chemical identity, purity and concentration (for example, a “specification and certificate of analysis”). However, it is recommended that the laboratory should independently verify their identity and purity (or concentration) before putting them to use (for example, by inter-laboratory comparisons or within the laboratory using a previously used reference standards).

This model therefore shows the headings for the sections of the Quality Manual as an outline structure. Details of the QMS can be inserted into the relevant places. Some sections may not be relevant and can simply be noted as “not relevant”. Conversely, a laboratory may need to introduce additional sections which do not appear in the general outline provided. Explanatory notes on information required to be included in the Quality Manual are indicated in italics in this Model. g. g. g. Laboratory director Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories Revision: Date: Laboratory name: Quality Manual Table of contents Record of updates to quality system Commitment to the quality system 1.

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