Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System: vision, concept and their potential impact on industry and regulators – will they foster innovation? ***

Michaela Krause (Abschlußjahr: 2007)

Language: English

There are different factors that triggered the new ICH Quality guidelines ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality Systems.
The development of innovative manufacturing technology is far behind the development of new complex drugs. Most of the investments for research and development have been spent for the discovery and development of new molecules but less for innovative manufacturing technology.
The quality of the information on pharmaceutical development varies in the drug dossiers. Besides it had a different significance in the application for marketing authorization within the three ICH-regions European Union, United States and Japan.
And the testing of product quality is guidance-oriented. It is fixed on prior determined specifications.

At the ICH meeting in Brussels in July 2003 a five-year Vision was agreed which aims to develop a harmonized pharmaceutical quality system applicable throughout the product lifecycle emphasizing an integrated approach to risk management.

The goal is to shift from a data based approach to a science and risk-based approach. Traditional empirical approaches will need to be replaced with a much more fundamental scientific understanding. This common goal requires a harmonized regulatory environment.
The development of ICH Q8 was triggered by the adoption and implementation of the CTD in the ICH-regions. The key concept is Quality by Design. Quality cannot be tested into the product but has to be designed and built into it from initial point to all elements of the manufacturing.
The key elements provided in ICH Q8 are Design Space and PAT. A Design Space facilitates regulatory flexibility. Risk-based regulatory decisions, reduction of post-approval submissions and real-time quality control are the potential benefits for industry and regulators. More detailed scientific knowledge on product and processes is required for this concept.

A quality risk management supports the identification and assessment of critical parameters influencing the product quality. ICH Q9 provides adequate risk management tools and two risk management principles for a harmonized approach to risk management.

The implementation of ICH Q8 and ICH Q9 requires a robust quality system. ICH Q10 describes a model for an effective quality management that applies for drug substances and drug products throughout the product lifecycle. ICH Q10 defines specific pharmaceutical quality system elements that augment the different regional GMP requirements.

The new concepts are not mandatory. Thereof, the degree of the impact will depend on the decision of industry and regulators on what level they will adopt the guidelines. Factors like company size, type of product, already implemented systems but also the expected benefit influence this decision.

Several benefits are expected with the adoption of the guidelines amongst others innovation, especially of manufacturing technologies. It is discussed if the guidelines will foster innovation. They at least provide a harmonized regulatory environment that reduces the regulatory burden for pharmaceutical companies. But just the availability of the guidelines alone cannot introduce new technologies or methodologies to pharmaceutical development and manufacturing. It is upon the industry and the regulators to adopt these new guidelines.

ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality System are inter-related and complement each other. Together they provide a regulatory framework to achieve the common Vision of the ICH-regions.

ICH Q8 is currently being updated and ICH Q10 has not been finalized yet. Already existing guidelines will need to be revised. It will be a step-by-step approach and the success will very much depend on the close co-operation between industry and regulators. There is still a lot of work ahead for both.

Pages: 41