What is PD CEN/TR 10345 – Guidelines for validation of analytical methods about?
PD CEN/TR 10345 is a technical report is a guideline to carry out the statistical evaluation of data from an interlaboratory test for method validation.
PD CEN/TR 10345 purpose is to detail the methodology of ISO 5725-1:1994, ISO 5725-2:1994 and ISO 5725-3:1994 for the treatment of the data collected under the conditions used within the ECISS/TC 102 working groups.
Note: PD CEN/TR 10345 is not a simplification of the ISO 5725 standard, which is the only reference document.
Who is PD CEN/TR 10345 - Guidelines for validation of analytical methods for?
PD CEN/TR 10345 on guidelines for validation of analytical methods is useful for:
- Data security
- Test laboratories
- Laboratory accreditation
- Biological analysis and testing
- Quality assurance management
- Statistical methods of analysis
Why should you use PD CEN/TR 10345 - Guidelines for validation of analytical methods?
An interlaboratory test for method validation is organized at each stage of the development of a standard draft. Changing economic conditions have led to the optimization of the work of the participating laboratories. The principle retained by ECISS/TC 102 is to have three values by participant laboratory: two values obtained in repeatability conditions (day 1) and a third obtained in intra laboratory reproducibility conditions (day 2). The data evaluation requires a complex statistical analysis, which may be very confusing for a non-specialist, even if it is widely detailed in the ISO 5725 standard. Consequently, it seems useful to clarify the methodology of PD CEN/TR 10345 for the above purpose and to underline those difficulties found should be discussed and solved with statisticians.
Values that are identified as statistically abnormal at 99 % (outliers) using numerical Cochran’s and Grubbs’ tests lead to the elimination of the laboratory that produced them, at the stage at which they are detected: this principle is adopted even though we risk wrongly eliminating one result in one hundred. Nevertheless, it is essential to advise the laboratory concerned about the reasons for these eliminations and to pay particular attention to this laboratory's results. Furthermore, in the case of a laboratory that produces values that are determined as statistically significant at 95 % (stragglers) by numerical Cochran’s and Grubbs’ tests, particular attention should be paid to all the other values produced by this laboratory. Using PD CEN/TR 10345 addresses how validation of analytical methods has become an important component of effective development and characterization. The use of experimental design to verify that a method can produce accurate and precise findings within the scope of its intended usage is known as method validation.
