PAT & QbD SUPPLEMENT


FMEA, design of experiments, robustness and ruggedness investigations, etc. However, one should keep the general definition of QbD in mind. Accordingly, in this paper, QbD for pharmaceutical analysis is understood as a general concept, a systematic approach starting from the requirements for analytical measurements (i.e. the intended use of the data), throughout the development phases, the industrial application, the management of changes until the end of the products lifecycle. Logically, such an approach will be strongly aligned with the manufacturing process and the desired product quality (seeFigure 1). An EFPIA Working Group, in joint


cooperation with a PhRMA Group, discussed implications and opportunities of such a systematic QbD approach and has published a position paper7


, in order to stimulate


further discussion within industry as well as with regulators.


Implications and opportunities of applying the principles of Quality by Design to analytical measurements A major point of concern for the Working Groups was the area of continuous analytical improvements. Although generally requested


Figure 1 Principles of Quality by Design for pharmaceutical product/manufacturing and for the corresponding analytical measurements


by authorities, regulatory practice often makes changes of analytical procedures difficult and tough. With the very essence of QbD, i.e. ‘beginning with the end in mind’ the concept of the ‘Analytical Target Profile’ (ATP) was developed. By means of the ATP, the requirements of analytical measurements are


established, which originate from the defined controls of the production process and of the product. These controls are reflected in the defined critical quality attributes (CQA)1


. The


paradigm change consists in establishing the requirements of ‘what’ needs to measured, and not the ‘how’, thus guaranteeing a close link


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