QbD as an improvement methodology for pharmaceutical

legacy products. A Case study.


 "Very logical, systematic, well explained and comprehensive. Great flow of the document aids practical implementation understanding: the background, definitions, presentations of available tools based on the topic (SPC, Risk Assessment, DOEs), linkage to the relevant regulatory guideline, building a business case with ROI-all this sets a great stage to the followed case-study that puts theory in practice. It is very useful to have everything in one comprehensive document." 


Director QbD strategy at TEVA.                                                                                                                


Description / Contents.


This is a 77-page document containing the results of the working sessions of a group of about 20 professionals from

the pharmaceutical industry and GMP inspectors.

The Case Study deals with the application of the QbD approach to the improvement of a tablets manufacturing process.

The purpose of this document is to help pharmaceutical companies in the gradual incorporation of QbD systems to

the manufacture of medicines. Specifically, it focuses on the manufacture of industrial batches.


This paper is structured as follows:

  • Chapter 1: Introduction.


  • Chapter 2: Evaluation of the state of control of manufacturing processes, criteria and statistical

                         tools to verify that the processes are stable and capable.


  • Chapter 3: Assessment of deficiencies in the design, and in the understanding of the manufacturing

                         processes as well as an improvement proposal; criteria and tools to acquire the necessary

                         knowledge of the process and to identify improvement actions and / or to redesign the process

                         if necessary.


  • Chapter 4: Criteria for calculating the ROI of a project based on QbD; methodology to prioritize improvement

                         projects and to calculate the necessary investment and savings estimations for each case.


  • Chapter 5: Case Study, application of the previous chapters to a fictitious example: improvement project

                         in tablet manufacturing.


  • Glossary of Terms.




This paper was the result of collaboration between ISPE Spain and the Pharmaceutical Control Services -

Department of Health of Generalitat de Catalunya.




“This Case Study is a translation of a work produced by an ISPE Affiliate. As such, it does not necessarily represent

the views or guidance produced by ISPE.  ISPE has not performed any peer reviews and does not endorse its content.

  It is published simply as a ‘real world’ case study and is intended to provide examples of some aspects of the

application of Quality by Design (QbD) for a legacy product (including examples of application of statistics, design

of experiments, return on investment,  and developing a control strategy) from which ISPE members and others

may benefit.”

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