Accelerate and simplify your path to market by using our Millipore® Validation Services to select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing and processing. You can rely on our experience to avoid regulatory observations and delays in your approval process.
Helping you choose the right validation services, our validation project managers possess intimate knowledge of global and local regulations and industry best practices. We can assist you in developing and implementing an appropriate validation strategy – determining what, how, and when to test, spanning upstream, downstream, or final fill operations.
Recommendation, based on the pharmaceutical application and risk assessment
As part of our industry-leading validation services for biopharmaceutical manufacturers, we offer these specialized capabilities at laboratories worldwide.
Regulatory guidance documents provide a framework to manufacturers for the production of drugs that are safe for administration to patients.
Any product or process change that could potentially affect the cGMP compliance of a validated process or system should be evaluated and a risk assessment should be performed to evaluate the impact.
Our experienced Validation Services team has summarized best practices for validating performance of critical filtration systems used in aseptic processing. If you need help, they can provide support on the various tests to meet global regulatory requirements.
This webinar describes a scientific, risk-based approach to change management and a roadmap for biomanufacturers to expedite changes in their post-approval processes.
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