Our validation studies have been split into 3 separate types. This allows our clients to save money if they have a very specific destination for the product registration. Alternatively they can add additional parameters in an attempt to future proof studies for products which may end up with multiple country registrations.
Level 1 - Our Basic European Registration
This suite has been written based on the multiple registration interpretations of SANCO/3030/99 (revision 5). It will be updated immediately as soon as the latest version of the regulations are released. We constantly update our validations to reflect the feedback from registration managers within the government departments of each country.
This includes Linearity at least 6 points in duplicate:
Sample Precision 6 samples assayed with associated %RSD
Sample Recovery 6 samples spiked with the relevant concentration of analyte
LOQ Recovery 6 samples spiked with the relevant concentration of analyte at LOQ
Specificity Assays to show that the formulation or impurities do not interfere with the analyte assay
Spectral Analysis: Analysis of the sample by HPLC-DAD, LC-MS, GC-MSD or LC-Q to F (Quadrapole Time of Flight) to provide spectral confirmation of the identities.
Our second level of validation includes all of the details required for European registration alongside the requirements for North and South American registration.
This means the reporting is enhanced with greater detail about the analysis and reagents used along with a more detailed reporting format.
The validation spectral analysis is greatly enhanced. All five samples are now individually assayed to produce seperate spectral data from FTIR, UV and Mass Spectral sources. The UV data is then plotted in a 3D form to determine the spectral purity of each sample.
Finally our third level of validation encompasses the testing from both European and American registration, including to Brazilian ABNT NBTR regulations. Added to this are the Australian requirements. This adds a large number of extra linearity points to meet all guide line requirements. The recoveries are then conducted at 4 different levels to resolve the additional recovery requirements.
Since we have been offering this level of validation we have not encountered a Country that has asked for any additional parameters although regulatory requirements continue to evolve.