Special collaboration with ISPE Spain and local GMP inspectors (Generalitat Catalunya)

This is one of the collaborations that makes us feel proud. We participated as co-authors and in the coordination of the working group that drafted this document.

To learn more, attached an excerpt and index content from the version published by the Department of Health (Catalan) in December 2014 and translated into English by ISPE Spain.

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 in 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.”