Validation and revalidation of analytical methods

  • choice of parameters and drawing up programs/plans of validation of analytical methods used in standardization and quality control of pharmaceuticals, dietary supplements, products of functional nutrition, cosmetics based on natural and synthetic materials;
  • validation of analytical methods for biopharmaceutical studies in vivo and in vitro;
  • validation of analytical methods for measurements performed by the following methods:
    • gravimetric;
    • titrimetric;
    • spectrophotometric;
    • high performance liquid chromatography (HPLC);
    • thin layer and high performance thin layer chromatography (TLC and HPTLC);
    • gas-liquid chromatography (GLC);
    • immunosorbent assay (ELISA).
  • determination of validation parameters:
    • Specificity/Selectivity;
    • Linearity, Range;
    • Repeatability/Precision;
    • Accuracy;
    • Robustness/Stability;
    • Recovery;
    • Limit of detection;
    • Limit of quantification;
  • validation of analytical techniques used in quality control by the following indicators:
    • Authenticity;
    • Dissolution;
    • Determination of impurity;
    • Residual organic solvents;
    • Uniform dosing;
    • Quantitative determination;
  • compilation of reports about validation (validation protocols) necessary for registration of normative documents (manufacturer monograph) about substances and pharmaceuticals, data representation of biopharmaceutical studies (in vitro, in vivo) of pharmaceuticals, dietary supplements, functional nutrition, cosmetics, etc

Validation procedures are carried out in accordance with the following requirements:

  1. OFS.1.1.0012.15 Validation of analytical methods. // State Pharmacopoeia of the Russian Federation. XIV ed., Moscow: Ministry of Health of the Russian Federation, 2018, Vol. 1-4. 7019 p.
  2. Guidance on the validation of analytical methods for testing drugs. Approved By the decision of the collegium of the ECE countries of July 17, 2018, No. 113. 2018. 26 p.
  3. Guidance on the validation of drug analysis techniques. M., Ministry of Health and Social Development of the Russian Federation, 2007. 49 p.
  4. ICH, Q2A, Harmonized tripartite guideline, text on validation of analytical procedures, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March 1994, pp. 1–5.
  5. ICH, Q2B, Harmonized tripartite guideline, validation of analytical procedure: methodology, IFPMA, in: Proceedings of the International Conference on Harmonization, Geneva, March 1996, pp. 1–8.
  6. Guidance for Industry: Bioanalytical method for validation. – Rockville, MD, U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Center for veterinary medicine, 2018. – 44 p.
  7. Guideline on bioanalytical method validation. EMEA/CHMP/EWP192217/2009, London, Committee for medicinal products for human use (CHMP), 2011. – 22 p.