The following bibliography for definitions may be used to find the recent definition from authoritative sources. Some definitions are not directly applicable to laboratories and some terms have multiple definitions. The lab should review the definitions and select the one that is most applicable to their use.

In addition, a list of terms and definitions not found in the authoritative sources is provided following the bibliography. This approach was chosen to ensure that the most current internationally harmonized definitions and terms are specified.

Terms and Definitions Bibliography

	1)	JCGM 200:2008 International vocabulary of metrology — Basic and general concepts and associated terms (VIM) Vocabulaire international de métrologie — Concepts fondamentaux et généraux et termes associés (VIM) © JCGM 2008 http://www.bipm.org/en/publications/guides/vim.html This 3rd edition cancels and replaces the 2nd edition, 1993. This 3rd edition is also published as ISO Guide 99 by ISO (ISO/IEC Guide 99-12:2007 International Vocabulary of Metrology – Basic and General Concepts and Associated Terms, VIM).
	2)	Conformity assessment –Vocabulary and general principles. ISO/IEC 17000:2004
	3)	Quality management systems –Fundamentals and vocabulary. ISO 9000:2005
	4)	Terms and definitions used in connection with reference materials. ISO Guide 30:1992
	5)	Revision of definitions for reference material and certified reference material. ISO Guide 30:1992/Amd 1:2008
	6)	Standardization and related activities –General vocabulary. ISO Guide 2:2004
	7)	United States Pharmacopoeia and National Formulary (USP/NF) http://www.uspnf.com/uspnf/login
	8)	European Pharmacopoeia http://online.pheur.org/entry.htm
	9)	International Committee of Harmonization (ICH): Q2(R1): Validation of Analytical Procedures: Text and Methodology. http://www.ich.org
	10)	Official methods of Analysis of AOAC International 18th Edition, http://eoma.aoac.org

Additional Definitions

1. Certified reference culture: Microbiological; a reference culture certified by technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body; e.g., cultures used for verifying test systems, validation of methods; quality control of test media must be traceable to a type culture collection.
   
   
2. Controlled document: A document that is subjected to controls to ensure that the same version of the document and any revisions are held by or available to all personnel to whom the document is applicable.
   
   
3. Empirical method: A method that determines a value that can only be arrived at in terms of the method per se and serves by definition as the only method for establishing the accepted value of the item measured.
   
   
4. Laboratory: Body that calibrates and/or tests.
   
   
5. Laboratory control sample: See Quality control sample.
   
   
6. Pharmaceutical testing laboratory: Laboratory that performs tests on finished pharmaceutical products, ingredients, raw materials, in-process samples, and associated environmental samples.
   
   
7. Quality control sample: A test portion sample with known contents of analytes to carry through the method to verify performance.
   
   
8. Reference culture (RC): A culture with characteristics sufficiently well established to be used to calibrate/verify test systems, and test media and to validate methods, e.g., cultures used for verifying test systems, and validation of methods; in addition to the use of "wild strains," quality control of test media shall also be traceable to a type culture collection.

Comment:


• For some analyses, such as screening tests for high consequence pathogens, Reference Cultures are not available to the testing laboratory. In this case, a culture with suitable properties should be used as a reference. The required properties of this culture should be characterized by repeat testing, preferably by more than one laboratory.
  
  
9. Replicate tests: An analysis of a laboratory sample, Certified Reference Material, or Reference Material can be performed more than once; the result of each individual analysis is a replicate test result. The replication can occur at any step in the procedure from laboratory sample, to test sample, to test portion, to test solution, to aliquot.

Comment:


• An analytical method final result can be the average of more than one interim value.
  
  
10. Reportable Value or Reportable Result: A final analytical result. This result is appropriately defined in the written approved test method and derived from one full execution of that method, starting from the original sample.
    
    
11. Sample: Any material brought into the laboratory for analysis.


12. Sample handling: The manipulation to which samples are subjected during the sampling process, from the selection from the original material through the disposal of all samples and test portions.


13. Sample preparation: This describes the procedures followed to select the test portion from the sample (or subsample) and includes in-laboratory processing, mixing, reducing, coring and quartering, riffling, and milling and grinding.


14. Segregate: To set apart; can represent setting apart by space and time. An example would be the separation (segregation) of samples and standards to avoid cross-contamination.


15. Test method: Specified technical procedure for performing a test.


16. Test portion: The actual material weighed or measured for the analysis.