PAT & QbD QUALITY BY DESIGN:


SUPPLEMENT


A LIFECYCLE CONCEPT FOR PHARMACEUTICAL ANALYSIS


Joachim Ermer Head of Quality Control Services Frankfurt Chemistry, Sanofi


Quality by Design for pharmaceutical analysis is regarded as a general concept starting from the requirements to analytical measurements, throughout the development phases, the industrial application including changes until the end of the products lifecycle. Adapting the QbD approach well known for manufacturing processes to pharmaceutical analysis, a Working Group of the European Federation of the Pharmaceutical Industries and Associations (EFPIA) has published a position paper. The core concept consists in the establishment of an Analytical Target Profile (ATP), where the requirements of what needs to measured is defined, instead of the traditional ‘how’. This concept would guarantee a close link between the suitability of the eventually chosen analytical method and the manufacturing process and product requirements.


It is proposed that the ATP is submitted to and approved by regulatory authorities, instead of an individual analytical procedure. Any analytical procedure conforming to the defined ATP criteria can be applied by internal change control management. Background information is given with respect to the performance characteristics of an ATP and the various stages of the analytical


16


European Pharmaceutical Review Volume 16 | Issue 3 | 2011


life cycle, such as method selection and evaluation, optimisation, method control strategy, validation, transfer and change management. The proposed concept is illustrated using a ‘mock’ example of water determination in a drug substance. Considerations and possible scenario through the life cycle of such an application are presented.


The topic ‘Quality by Design’ (QbD) for


pharmaceutical products and manufacturing processes has been extensively discussed in the last years and is of common interest for both the pharmaceutical industry and regulators1-4


.


It is understood as a ‘systematic approach … that begins with predefined objectives and emphasizes product and process under- standing and process control, based on sound science and quality risk management’1


. The aim is


to achieve the desired quality of a pharma - ceutical product consistently and reliably and to help the regulators to better understand a company’s strategy. Of course, such goals are equally desirable with respect to analytical controls of these manufacturing processes. Therefore, it is only a logical consequence to apply the QbD concept to analytical procedures5,6 In the past, this was often focused on the application of QbD tools such as risk analysis,


.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25