Method validation.
Innovative analytical procedures are not only required when drawing up marketing authorisation dossiers, they are also needed to control the quality of new plant-based products. In this respect, PhytoLab develops and validates new test procedures - within the framework of new statutory requirements or officially regulated risk management procedures, or for various institutions and committees (e.g. DIN/ISO committees, German and European Pharmacopoeia Commissions etc.).
The availability of extensive validation data is a crucial factor that contributes towards obtaining dependable results of analyses and therefore plays an important role in terms of improving product safety.
The scope of validation is laid down in the international guidelines drawn up by the ICH, International Conference on Harmonisation (www.ICH.org and www.emea.eu.int). The detailed information required for validation can be found in the guidelines under ICH Topic Q2A (CPMP/ICH/381/95), Validation of Analytical Methods: Definitions and Terminology und ICH Topic Q2B (CPMP/ICH/281/95) Note for Guidance of Analytical Procedures: Methodology. The US Food and Drug Administration (FDA, www.fda.org) has also published guidelines for the validation of methods and procedures (Guidance for Industry, Analytical Procedures and Methods Validation).
The validation procedure involves the systematic verification of an analytical method or procedure in terms of repeatability, intermediate precision, determination of accuracy and linearity (linear range), as well as determination of the detection and quantitation limits when analysing residual substances. The robustness of sample preparation and the chromatographic separation of a method are already verified by varying critical parameters during the method development stage. Our customers receive recommendations on the scope of validation in an offer with modular structure.
As far as the development of new methods and procedures is concerned, PhytoLab's customers not only benefit from our experimental and analytical experience, but also from the use of modern, computer-aided simulations of HPLC chromatograms. These offer PhytoLab a means of rapidly optimising all of the relevant chromatographic conditions to produce highly dependable HPLC methods, which can be easily adopted in the daily routine.
All of the raw data are recorded and filed to ensure that comprehensive documentation of all relevant validation information is available for a final report. The validation documentation may also be drawn up in English if required, and can be directly incorporated into the marketing authorisation dossier. You may choose to do this yourself or ask our Regulatory Affairs department (registration) to do this work on your behalf.
Methods and procedures developed and validated by PhytoLab are also finding their way into U.S. regulations and standards (e.g. AOAC or USP) thanks to PhytoLab's active involvement in the Method Validation Program launched by the Institute for Nutraceutical Advancement (INA, www.nsf.org or www.nsfina.org) in its capacity as an official validation laboratory.
PhytoLab is also an active member of AOAC International (www.aoac.org). We actively support the validation process for many methods and procedures for plant-based products. This process (detailed information can be found at http://www.phytolab.de/news/glucosamin.php) culminates in official AOAC methods and procedures which are included in the AOAC's "Official Methods of Analysis" and are used by the industry and official authorities all over the world.
Many of our methods are reviewed at regular intervals as a consequence of our involvement in international pooled testing schemes, e.g. FAPAS® proficiency testing (www.fapas.com). This involvement is also a result of the requirements for our accreditation in accordance with EU Directive 93/99/EEC.
