GMP Spezial

This book is written with all stakeholders in mind; the regulatory agencies and the healthcare industry, including their suppliers. As the process of adoption, implementation and interpretation of Quality by Design is currently the key driver to help industry bring products to market faster and at the same time provide maximum assurance of product quality. Though pharmaceutical companies need to abide the law and therefore comply with the applicable laws, rules and regulations, their goal must be to be profitable. A business case must therefore not only outline how compliance can be achieved, maintained and improved, but also how this will result in a positive financial impact. Global subject matter experts offer invaluable information that will guide companies who wish to:

- Proactively address regulatory trends
- Reduce or eliminate the number of reworked batches
- Achieve better manufacturability and process robustness
- Drastically reduce recalls
- Achieve leadership in the industry

Cutting the cost of drug development is an overarching goal for the entire pharmaceutical industry. Any program that promises to make a significant contribution to it will certainly be welcome. Drug regulatory authorities almost anywhere base their decisions on three criteria: quality, efficacy and safety. They take no account of the actual or potential cost of the product to the company. Consequently, in addition for a need to be compliant with regulatory requirements there is an equal imperative for industry to examine the value for money they get from process development and acquisition of knowledge.

Table of Contents

- Chapter 1: Introduction by Siegfried Schmitt
- Chapter 2: The Regulatory Framework by Siegfried Schmitt
- Chapter 3: The Roadmap to QbD by Siegfried Schmitt
- Chapter 4: Simplified Process Development and Commercialization by Girish Malhotra
- Chapter 5: Change Management Associated with QbD Implementation by Michael Schousboe and Irwin Hirsh
- Chapter 6: QbD and Process Validation — Complementary Lifecycle Approaches by Paul L. Pluta
- Chapter 7: The Analytical Challenge in QbD — From Data to information and to Knowledge — From (Bioprocess) Development to Manufacturing by Christoph Herwig
- Chapter 8: Applying QbD Design to Pharmaceutical Microbiology by Jeanne Moldenhauer
- Chapter 9: The QbD Challenge for Analytical Laboratories by Terry Hopper
- Chapter 10: Compliance by Design (CbD) and Compliance Master Plan (CMP) — Lifecycle Approach to Quality Systems and Compliance by Paul L. Pluta, Richard Poska and Timothy J. Fields
- Chapter 11: The Regulatory Perspective for Small Molecules Related to Variations by Salma Michor
- Chapter 12: Role of the University in Teaching QbD by Siegfried Schmitt

Siegfried Schmitt, Principal Consultant, joined PAREXEL Consulting in 2007. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance. Dr Schmitt`s areas of expertise include all aspects of quality and compliance for the product lifecycle, from R&D, to clinical trials, to commercialisation and post-marketing studies. He has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare, and as Validation Manager with Raytheon and Senior Lead Consultant with ABB. Dr Schmitt is an active member of various industry associations, including DIA, PDA, RAPS and ISPE, conference presenter and organiser of international events. He is also an accomplished author and editor, having won the coveted ‘distinguished PDA author / editor award’ for 2008. Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status. He is fluent in English and German.