Critical Elements of Knowledge Management in a Pharmaceutical Quality System

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

• It is critical that tacit knowledge (knowledge that is "in the head") is converted to explicit knowledge (knowledge that is documented and able to be disseminated).
• Ensure that knowledge management is incorporated in processes by utilizing logical standardized procedures to define requirements for documenting information and minimum requirements for the type of data to obtain in specific processes.
• Be vigilant for innovative technology to apply to your processes (can your processes be improved upon?)
• Assign responsibilities for knowledge management (for example, who is responsible for acquiring and documenting data?)
• When in doubt, document. The acquired information may have relevance in another stage of the product lifecycle.
• Store acquired information in a secure manner (e.g. document management system, controlled database, etc)

2. Information Distribution

• Acquired information needs to be communicated internally (and potentially externally). Document management systems, libraries, databases, etc. are all systems that are capable of controlling and promoting access to specific information.
• Management should advocate effective communication of information and empower employees to share information in an open and effective manner. Retaining knowledge (tacit knowledge) should be discouraged by management.
• Quality-related processes should be promoted by management and communicated to all levels and functions within an organization. Communication should be encouraged between all levels (upwards and downwards) of an organization.

3. Information Utilization

• Since knowledge management and enhanced process understanding are critical to continuous improvement, pharmaceutical companies should make a concerted effort to collect all relevant technical and quality data, store data in a secure environment (physical or electronic) and communicate or provide access to all levels of an organization.

“Knowledge is of two kinds. We know a subject ourselves, or we know where we can find information on it.” –Samuel Johnson (1709-1784)