A GMP requirement
Test method validation provides assurance that a method is suitable for its intended use.
It is a GMP requirement that licensed products have their test methods validated. When applied to microbiological testing this confirms that the product does not influence the recovery of microorganisms that may be present. For certain products, such as solid-dose, this is especially important. The proportionately high levels of the active ingredients mean refinements to the test methods are often required.
At MCS we have extensive experience across a wide range of product types ensuring we can validate your product.
With all licensed products we are also obliged to have a microbiological specification for the sample before we commence testing.
For further information and technical details please see our method validation Technical Information.