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GMP Chemistry Analytical Method Development
When your methods require the highest standards, we are your perfect partner to develop them. With vast experience in the pharmaceutical industry our GMP chemistry laboratories can develop QC methodologies for your products that are compliant for use in pharmaceutical manufacturing environments.
Analytical method development and validation are critical components of any pharmaceutical development program. They help ensure your process and product purity profiles meet acceptance criteria, and are also an integral part of final submission.
We develop and validate methods to ICH guidelines which include the following parameters:
- Linearity
- Limit of detection (LOD)
- Limit of quantification (LOQ)
- Specificity (including stability of solutions)
- Precision (method, intermediate and system)
- Accuracy (recoveries)
- Robustness
- Forced degradation
Method Development
Whatever your product, material or process we have the expertise to help. We can help you to assess any risks related to impurities, whether related to packaging (Extractables and Leachables), raw materials or manufacturing processes. We can also provide support for cleaning validations of production lines, amongst many other offerings.
Method Validation
Our pharmaceutical method validation service will ensure that your analytical processes are suitable for application in your drug development program. Method development can help to improve the whole drug production process, but it is also important that your methods are fully validated to support regulatory submission of your products.