Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 44

So what is it that ties the three GXP disciplines together? It is the culture of quality and building quality into all aspects and processes that are employed. If you turn to Chapter 30 and the diagram depicting the quality management system you can visualize that whether the investigational product is being manufactured, undergoing preliminary testing to assess its toxicity, or being administered to humans as part of a clinical trial the same set of quality characteristics are brought to bear.

Qualification of people, places, and things must be performed against a standard or set of criteria. Training must occur not only in the general aspects of the discipline but also in the details which apply, for example a clinical trial protocol. Written procedures must be in place, trained against and followed. Keeping written procedures current is one of the most demanding, but necessary aspects of this quality characteristic. Maintaining records and documentation which is accurate and complete cannot be overemphasized. Documenting data and events whether by hand or electronically is essential; however, it remains one of the quality activities that is the most difficult to convince people is critical. Keeping records is not viewed as fun by many people. Ensuring that all involved parties and systems are engaged when making changes is a management step that demands inclusiveness. Operating under a management system that has identified the risks associated with the trial and which represent a critical to quality categorization along with any planned mitigation is a characteristic which evolved from the medical device manufacturing arena but has become an accepted and necessary practice throughout GXP. Learning and making changes based on implementing a corrective and preventive action program is also a process which was born in the medical device regulatory scheme but adds value to the clinical trial endeavor because it forces systematic change not just one off corrections. From the Quality Assurance standpoint auditing programs either internally or by external parties highlights not just the issues but also the successes in a program. Lastly having the involvement of management that is empowered to make changes and is committed to doing so when needed is key to completing the GXP scheme in general and GCP is particular.