Validation and Consultancy Services
Biopharmaceutical manufacturers worldwide must constantly keep pace with an increasingly regulated environment. The validation work, documentation and administration required to do so is time-consuming, and very often means a shift in focus from the manufacturing of the product itself, to perform the required regulatory tests. In many cases, the supplier of a testing method or a contract laboratory has specialized knowledge that could ease the burden of this workload for manufacturers and free their resources for other tasks.
Test method validation also consumes resources in the quality control unit of a manufacturer. As the largest supplier of quality testing products, Millipore can assist with the time-consuming validation of these test methods. We offer ready-to-use IQ/OQ/PQ protocols, on-site qualification of hardware, on site consulting support for test method suitability validation as well as method development.
We can support the quick implementation of a critical test that is fully compliant with current regulations. Millipore also offers a range of maintenance services and contracts.
In addition, some test methods require resources that many companies may not possess on-site. In such cases, companies can choose to partner with external laboratories to conduct the tests. MicroSafe Biosafety Solutions Laboratory, Europe from Millipore is a GMP/GLP microbiological contract testing facility that meets the drug manufacturing testing needs of pharmaceutical and biotechnology companies, including gene therapy and veterinary applications throughout Europe.
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