Analytical Method Validation/ILV for determination of residues

Validation of the analytical method, or  ILV of a  primary method supplied by another Facility and already validated, to determine residues in plants, plant products, foodstuffs (of plant and animal origin), feedingstuffs and environmental samples.



STUDY
DESIGN

Preliminary custom set-up
Just for the Analytical method validation, test design may includes an entirely new method set-up and optimisation or a checking/confirm of the analytical method supplied by the Sponsor or even a checking of the analytical method from reference literature.
Analytical method validation or ILV consist of:
Linearity (checked at each analytical sequence) with at least 5 concentrations of analytical standard in the appropriate range of concentrations diluted with untreated matrix extract.
Recovery and Precision with 2 Fortification levels on the untreated matrix: LOQ and 10xLOQ (or other suitable level) with 5 samples for each level
Acceptable ranges for the recovery and the precision depend on the matrix and the fortification level.
Interferences check 2 samples of untreated blank to check interferences, analytical artifacts and matrix effects: the  analyte signal must be < 30% of LOQ.
where LOQ is defined as the low fortification level at which mean recovery and precision are acceptable.
LOD defined by Signal to Noise Ratio < 3.
Confirmatory analysis consists of additional MS/MS transition on:
- Linearity data (5 concentrations)
- Recovery and precision data at LOQ level (5  samples)
- Untreated blank data (1 sample)
If no additional transition is identified a confirmatory method is performed.
Additonally, the stability check of stock/working solutions and the stability check of the final extracts per matrix type can be carried out.
Study includes GLP managment and reporting.

REFERENCES AND GUIDELINES
SANCO/3029/99 rev. 4 (11/07/2000) - Residues: guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (Part A, section 4) and Annex III (Part A, section 5) of Directive 91/414.
SANCO/825/00 rev. 8.1 (16/11/2010) - Guidance document on pesticide residue analytical methods.

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Scientific Contact

Anna Paola Fifi
E-mail: apfifi@biotecnologiebt.it
Phone: +39 075 895 0045 - Ext. 268
Anna Maria Pavesi
E-mail: ampavesi@biotecnologiebt.it
Phone: +39 0371 4662 - Ext. 711

Business contact

E-mail: marketing@biotecnologiebt.it