Analytical Method Development
Analytical method development is important for both the early and advanced phases of the product lifecycle. As such, analytical methods used in raw material analysis, in-process testing, release testing and cleaning validation/verification associated with GMP biopharmaceutical products are validated, qualified, or verified, as appropriate for the stage of the product. Development of these methods is carried out in such a way that the type and scope of the data generated will allow for sufficient evidence of the reproducibility of the process and in accordance with the industry standards of analysis (i.e., precision, accuracy, limit of detection, limit of quantification, specificity, range and robustness).
Development of a project’s methods will focus on designing studies and generating data based on critical criteria outlined in the Project Specific Master Validation Plan and will include a gap analysis and remediation planning. The end result of development is a method poised for use in the project life cycle.