Method Development & Validation
Method Development and Validation
Vici Health Sciences offers analytical method development and validation as a stand-alone service or as part of a full product development package. Being a full service, end-to-end product development CDMO, we are experts in all aspects of HPLC analytical method development, testing, and validation. We perform ID, assay, dissolution, impurity, content uniformity method development and validation, and can guide your overall program with meticulous troubleshooting when necessary. Vici is your one-stop R&D experience.
Why is analytical method development needed?
Analytical methods need to be developed for a specific drug product being developed or manufactured. Compendial or literature methods do not work for all products due to varying strengths, inactive ingredients, and manufacturing technologies used. Compendial methods or methods developed and validated by drug substance (API) vendors can be used for drug substances upon completion of method verification or method transfer. Full method development and validation is not required for drug products when transferring in validated methods. Get in touch with our analytical chemistry scientists or regulatory experts for a complete understanding of the unique requirements for your project.
What is analytical method validation?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in conjunction with regulatory agencies including the Food & Drug Administration (FDA) provide detailed guidance on the requirements for analytical method validation of pharmaceutical products. Validation establishes methods for the following:
- Specificity/Selectivity
- Range
- Accuracy
- Precision
- Robustness
- Specificity/Selectivity
- Range
- Accuracy
- Precision
- Robustness
When is analytical method validation necessary?
Testing for pharmaceuticals must be performed using appropriately validated analytical methods for the product to be considered cGMP. This includes for human clinical studies, demonstrating bioequivalence in vitro in an FDA filing, supporting manufacturing process validation, or for commercially distributed products. It is generally not needed during the R&D phase of drug product development.
Is analytical method validation for clinical trial material the same for commercial product?
The FDA utilizes the concept of phase appropriate method validation. This concept focuses on patient safety with increasing stringency as the clinical program goes from early to later stages of FDA approval and commercial manufacturing. Vici Health Sciences is well versed in this concept and can guide you through the specific requirements at each stage of your program, saving you time and money.