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Analytical QA

Q: What is the concept of "Analytical Quality Assurance"? What aspects of manufacturing does it include?

A: J. Scott Tarpley answers:

The name "Analytical Quality Assurance" isn't commonly used. However, what it means to me is the scientific approach to assuring quality as opposed to a constant reliance on exhaustive and expensive inspection, testing, and documentation. Analytical QA first would encompass understanding what are the key quality attributes (or outputs) and key process parameters (or inputs).

The key process parameters would also include important characteristics of excipients and raw materials normally found on Certificates of Analyses (CoA). Further, utilization of control charts on the data produced in the manufacturing processes to segregate special cause variation from common cause variation would exist — as well as deployment of statitical analyses and design of experiments to determine the optimum settings for all process parameters.

Most all of regulatory bodies globally are moving to more of this analytical approach. Other industries have been applying this approach successfully for 30 to 40 years. Ultimately, Analytical QA should move into the research, design, and co-development cycles for all new products. If products and processes are developed to higher capabilities prior to mass-production, the manufacturers enjoy the benefits of robust, predictable processes — not to mention much greater confidence from the regulator (customer).

Analytical QA in my opinion would include all facets of manufacturing — QO, production, engineering, technical services, procurement, etc.— and across sites from suppliers to API to drug product to packaging and distribution. In other words, a holistic view of product-based process capability is the approach of Analytical QA.