The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS guidance is to strengthen the link between pharmaceutical development and commercial manufacturing through continuous feedback, process controls and management oversight.
When considering all of the technical and quality-related aspects of each stage of a product’s lifecycle, it is easy to understand why knowledge management was specifically called out in the guidance as an enabler to the success of the PQS implementation and management. For example, when developing a pharmaceutical product, a tremendous amount of data is generated in the form of developmental studies, clinical evaluation, process optimization studies, method development, risk assessments, etc. to establish the design space, process parameters and quality attributes used in commercial manufacturing. Essentially, the enhanced knowledge of a product gained during development facilitates the implementation of controls and assurances of quality during commercial manufacture. Without a system to gather, distribute and utilize the data generated during development, the product lifecycle ceases to progress and commercial manufacture or technology transfer will be overwhelmed with quality and regulatory issues, if the drug application is approved in the first place.
Per ICH Q10, knowledge management is the systematic approach to acquiring, analyzing, storing and disseminating information related to products, manufacturing processes and components. The following are critical elements in ensuring an effective knowledge management system that meets the intent of the ICH Q10 guidance:
1. Information Acquisition
2. Information Distribution
3. Information Utilization
“Knowledge is of two kinds. We know a subject ourselves, or we know where we can find information on it.” –Samuel Johnson (1709-1784)