Validation of Rapid Microbiological Methods

Validation of Rapid Microbiological Methods

Matrix validation is required to confirm whether your specific matrix is compatible with one of the analytical methods available in our laboratory. As a rule, only certain parameters need to be checked in manufacturer-validated kit systems and processes implemented in the laboratory. In the case of a limit test, this could mean that it is sufficient to check a limit specified by the pharmacopoeia together with the robustness of the method over three batches of your product. If there is no limit specified by the pharmacopoeia, it may be necessary to determine this in your matrix as part of a more extensive validation. Statistical methods such as the probit method for determining the LOD95 might need to be considered in these more extensive validations. The scope of the validation is sometimes very individual to your product should be coordinated with the responsible authority. Timely coordination with your authority avoids unnecessary revalidation work, costs and loss of time. In addition to the official requirements, your scope of validation depends on the number of analytical parameters you require and your needs for security and statistics. We would be happy to advise you on this and work out an individual validation plan tailored to your needs.

Background Information | Validation

Many of the methods used in our laboratory are either manufacturer-validated and / or described by the European Pharmacopoeia. An example of a method that has been validated extensively by a manufacturer is mycoplasma testing with the Microsart® ATMP Mycoplasma System (Sartorius Biotech GmbH). Framework conditions for mycoplasma test system validation are defined by the European Pharmacopoeia 2.6.1. Further, the ICH guideline ‘Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology (short: ICH Q2 (R1))’ defines the scope to be validated  e.g. Test for Impurities – limit tests.

If the method has already been validated so extensively, why should the method be subjected to a “matrix validation” again? The framework conditions for this are in turn defined by the EU-GMP. No manufacturer validation can cover every manufacturing process or matrix. Biotechnological products are often unique even when using the identical cell culture medium. For example, using a different cell type or species in the same background can make a big difference. The origin of this lies among other things in different cell compositions or in the production and secretion of heterologous proteins, antibodies or cytokines. Another reason for matrix validation lies in the different manufacturing processes, so matrix validation ultimately also covers the storage and transport from your production site to our laboratory.

Validation Services | Overview

Validation Mycoplasma testing

EP 2.6.7 provides the basis for the method validation of our nucleic acid-based mycoplasma testing. In general, the most complex step is certainly the validation of the QPCR method. However, since we use a manufacturer-validated system, many chapters can be adopted directly. As a rule, proof of the sensitivity to be achieved (10 CFU / ml) and of the robustness must be provided for your specific matrix. Thanks to our intensive cooperation with kit manufacturers, we can rely on externally certified standards for all EP and JP listed mycoplasma species and provide you with a risk-based approach species selection approach. We would be happy to advise you on the required sample material (volumes, production batches and mycoplasma species) and work with you to develop a suitable validation plan. Benefit from our many years of experience in the GMP environment and our short mycoplasma validation times and contact us. The validation can be carried out for Intego, VitalAmp or MaxVolume. More information: Mycoplasma Testing