Quality by design
Quality by Design (QbD) is a concept based on the book "Juran on Quality by Design" by the Romanian-American industrial engineer Joseph M. Juran . This is a sub-area of quality management that already includes several quality tests during the product development process, which should enable more targeted error identification and more efficient error reduction. As a result, the required final quality of the product should already be achieved through targeted error-reducing measures in production. The Quality by Design concept has long been used in a wide variety of industries. The first indications can be found in the 1970s with the Japanese automobile manufacturer Toyota , whereas nowadays it is particularly popular in the biotechnological and pharmaceutical industries.
model
"Quality cannot be tested into products; it should be built-in or should be by design. "
“Quality cannot be built into products through testing; it should be built in. "
Joseph M. Juran was convinced that you can plan quality, which is why all problems that arise afterwards are due to incorrect planning. In order to avoid this it is on the one hand of great importance to have a comprehensive knowledge of material, development and manufacturing processes, on the other hand to know the risks and to assess them correctly.
In order to be able to implement all of these requirements, there are different approaches, which are divided into the design, the development and manufacturing process (phases 1–3) and risk assessment and risk control (phases 4–6).
Phase 1: product profile
In this phase, a product profile (Target Product Profile - TPP) is defined at the beginning, which defines all the required properties, mainly quality, effectiveness and safety. These are related to the interests and needs of the customers.
Phase 2: risk identification
The critical quality attributes (CQAs) are then named. These represent, for example, physical, chemical or biological properties that can or may only move within a certain framework. These properties have a great influence on product quality, which is why they must be carefully researched and controlled.
Phase 3: Product and process design
This is where the development of a suitable product process takes place, which takes into account and implements all the previously aimed goals in order to be able to produce the desired product.
Phase 4: risk analysis and evaluation
In this phase, the knowledge of the material properties used and the process comes into its own, in particular their effects on one another. It is a systematic process that is supported by experiments.
Phase 5: Risk Control
Risk control relates to the entire process and takes into account the variability of the material and the process as a whole. This phase is in close contact with the aforementioned phase of analysis and evaluation, so that material properties and process parameters can be precisely coordinated.
Phase 6: risk assessment
The risk assessment is understood to be a permanent control and regulation process that guarantees a permanent quality standard. It is based on all the information obtained from product and process understanding and links them.
This is by no means a rigid sequence of phases of development, but rather an interrelated chain of coordinated processes.
Application in the pharmaceutical industry
Quality by Design is used to a large extent in the pharmaceutical industry in the development and manufacture of drugs, but also in the course of the approval of new drugs. The concept was introduced into the pharmaceutical industry between 2009 and 2012 by the US Food and Drug Administration (FDA) in cooperation with the European Medicines Agency (EMA) using internationally valid guidelines. However, Quality by Design was used for the first time in 2006 for the blood sugar regulating drug Januvia from Merck & Co.
I organization
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global project that brings together the regulatory authorities of the United States , Japan and Germany (and the European Union) together with experts from the pharmaceutical industry to assess scientific and Discuss technical aspects of product registration in this industry. In this context, a cooperation with the FDA and the EMA emerged, which produced three guidelines:
- ICH Q8: Pharmaceutical Development: Describes scientific and risk-based approaches for pharmaceutical product and manufacturing process development.
- ICH Q9: Quality Risk Management: Basically relies on scientific evidence to provide an assessment of the risk, while the level of effort and documentation should be proportionate to the risk.
- ICH Q10: Pharmaceutical Quality System: Is an example of quality assurance throughout the entire product life cycle, which can be seen as an extension of the GMP guidelines that have already been passed .
literature
- JM Juran: Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. Free Press 1992, ISBN 0-02-916683-7
- Handelsblatt Management Library: The most important management thinkers, Campus Verlag 2005, ISBN 978-3-593-37818-3
Individual evidence
- ^ Juran, JM: Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services . Free Press, 1992, ISBN 0-02-916683-7 .
- ↑ What is QbD? (PDF) Accessed May 1, 2016 (English).
- ↑ Jürgen Paeger: A little history of quality management. Jürgen Paeger, accessed June 30, 2016 .
- ^ Lessons from the Auto Industry. (PDF) BioProcess International, 2007, accessed on June 29, 2016 (English).
- ↑ PAT / QbD - Pharma on the way into the 21st century. (PDF) Siemens, accessed June 29, 2016 .
- ^ Nethercote, Phil: Pharmaceutical QbD. Pharmaceutical Manufacturing, April 13, 2010, accessed June 29, 2016 .
- ↑ Sauter, Roman; Sauter, Werner; Zollondz, Hans-Dieter: Organization and Technology Management - Joseph M. Juan. Internet Academy and Textbook Publishing, accessed June 29, 2016 .
- ↑ QbD Drugs. (PDF) FDA, accessed on May 6, 2016 (English).
- ↑ QbD Introduction Pharma. Retrieved May 7, 2016 .
- ↑ QbD Pharma Industry. Vetter Pharma, accessed May 6, 2016 .
- ↑ Members & Observers: I. Retrieved February 20, 2018 .
- ↑ ICH Guidelines. Retrieved May 4, 2016 .
- ↑ GMP, ICH Q9, Q10. GMP, accessed on May 6, 2016 .