In R&D environment, "Knowledge" is residing in different silos...
*) literature - references (limited by accessibility - availability - application)
**) experience - expertize (dependent on judgement/discretion of scientist )
***) experimentation & data generated through trials/observations (constrained bythe interpretation and conclusions/inferences drawn)
****) then there is feedback from past executions/products/operations. (usually tied with RCA & CAPA)
so, my question (in above context/perception) is that..
1) How do you approach the task of establishing KM in R&D environment;
2) viz., monitoring RCA & implementation of (CA)PA , what are the other tools/elements which can be implemented in R&D area.
3) Is there a need to integrate the above elements of Knowledge.
4) How do you measure the effectiveness of the implementation;
This is what ICH&FDA has to clarify in Q&A on KM...
*) literature - references (limited by accessibility - availability - application)
**) experience - expertize (dependent on judgement/discretion of scientist )
***) experimentation & data generated through trials/observations (constrained bythe interpretation and conclusions/inferences drawn)
****) then there is feedback from past executions/products/operations. (usually tied with RCA & CAPA)
so, my question (in above context/perception) is that..
1) How do you approach the task of establishing KM in R&D environment;
2) viz., monitoring RCA & implementation of (CA)PA , what are the other tools/elements which can be implemented in R&D area.
3) Is there a need to integrate the above elements of Knowledge.
4) How do you measure the effectiveness of the implementation;
This is what ICH&FDA has to clarify in Q&A on KM...
Q1: How has the implementation of ICH Q8, Q9, and Q10 changed the significance and use of knowledge management?
A1: Q10 defines knowledge management as: “Systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components.”
Knowledge management is not a system; it enables the implementation of the concepts described in ICH Q8, Q9 and Q10.
Knowledge management is not a new concept. It is always important regardless of the development approach. Q10 highlights knowledge management because it is expected that more complex information generated by appropriate approaches (e.g., QbD, process analytical technology (PAT), real-time data generation, and control monitoring systems) should be better captured, managed, and shared during product life-cycle.
In conjunction with quality risk management, knowledge management can facilitate the use of concepts such as prior knowledge (including from other similar products), development of design space, control strategy, technology transfer, and continual improvement across the product life cycle. (Approved April 2009)
Q2: Does Q10 suggest an ideal way to manage knowledge?
A2: No. Q10 provides a framework and does not prescribe how to implement knowledge management. Each company decides how to manage knowledge, including the depth and extent of information assessment based on its specific needs. (Approved April 2009)
Q3: What are potential sources of information for knowledge management?
A3: Some examples of knowledge sources are:
Prior knowledge based on experience obtained from similar processes (internal knowledge, industry scientific and technical publications) and published information (external knowledge: literature and peer-reviewed publications)
Pharmaceutical development studies
Mechanism of action
Structure/function relationships
Technology transfer activities
Process validation studies
• Manufacturing experience, e.g.,
Internal and vendor audits
Raw material testing data
Innovation
Continual improvement
Change management activities
Stability reports
Product quality reviews/annual product reviews
Complaint reports
Adverse event reports (patient safety)
Deviation reports, recall Information
Technical investigations and/or CAPA reports
Suppliers and contractors
Product history and /or manufacturing history
Ongoing manufacturing processes information (e.g., trends)
Information from the above can be sourced and shared across a site or company, between companies and suppliers/contractors, products, and across different disciplines (e.g., development, manufacturing, engineering, quality units). (Approved April 2009)
Q4: Is a specific dedicated, computerized information management system required for the implementation of knowledge management with respect to ICH Q8, Q9, and Q10?
A4: No, but such computerized information management systems can be invaluable in capturing, managing, assessing, and sharing complex data and information. (Approved April 2009)
Q5: Will regulatory agencies expect to see a formal knowledge management approach during inspections?
A5: No. There is no added regulatory requirement for a formal knowledge management system. However, it is expected that knowledge from different processes and systems will be appropriately utilized.
Note: “formal” means: it is a structured approach using a recognized methodology or information technology (IT) tool, executing and documenting something in a transparent and detailed manner. (Approved June 2009)