What are the elements of Knowledge Management in R&D Environment...

v9991

Trusted Information Resource
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...
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)
 

Marc

Fully vaccinated are you?
Leader
A quick "Bump". My Thanks in advance for your input on this thread. With enough input this could be a good "knowledge base" information thread.
 

v9991

Trusted Information Resource
Though they are quite generic/broad in scope...Certain interesting and relevant links here...
you will find original article at last slide of ppt (due credits to the original team, mine is little effort to crisply provide an accelerator into concept of article)

http://www.sims.monash.edu.au/subjects/ims5330/resources/PharmaCorp case.pdf

http://ec.europa.eu/enterprise/arch...Case Studies 2005/CS_SR04_Pharma_6-Aureus.pdf

http://www.systems-thinking.org/kmgmt/kmlinking.pdf

http://www-935.ibm.com/services/th/igs/pdf/g510-1670-00-leveraging-knowledge-management.pdf
Industry Case Studies...(also look at references...) http://informationr.net/ir/8-1/paper141.html

Refer Last table in the document...(to apply the same to QRM)
http://www.iima.org/CIIMA/4 CIIMA 7-1-07 Adis 1-10.pdf ..

To explore/understand the approach outlined...(to adopt the framework)
http://www.campbellinformatics.com/Methodology for Knowledge Management.pdf
 

Attachments

  • KM.pptx
    605.6 KB · Views: 232
Last edited by a moderator:

Chennaiite

Never-say-die
Trusted Information Resource
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;

We have initiated quite a few programs towards Knowledge Management, of late. One is a technical discussion forum like the one we are in. There is also a Knowledge sharing session on every Friday second-half which is open for anyone to participate. This is organized by our training department and people voluntarily come forward to share their knowledge on a specific topic, say Engine, Gearbox, etc. The other one is a Knowledge bank in our portal where the Knowledge such as new technology, Standards, Design calculations, Benchmark data, learning from RCA/CA can be shared. We even went to an extent of doing FMEA for the latter. Significantly, we have created a separate function to manage these Knowledge Management Programs.

As for the effectiveness measurement of these initiatives, we have not reached that far but inputs from this thread and other sources should help. But it's like sowing a seed, if only the Top Management nurtures it, you get there apples in due course. A typical Top Management would normally under estimate the value of initiatives such as these as much as they do with Training programs, just because they don't show a tangible short-term result.
 

somashekar

Leader
Admin
An other element of this knowledge is to let go the books, computers and go to the field and see what is happening over there presently, talk to target people and get the feel and pulse. After all R&D must have the end customer focus in order to meet that need.
 

v9991

Trusted Information Resource
We have initiated quite a few programs towards Knowledge Management, of late. One is a technical discussion forum like the one we are in. There is also a Knowledge sharing session on every Friday second-half which is open for anyone to participate. This is organized by our training department and people voluntarily come forward to share their knowledge on a specific topic, say Engine, Gearbox, etc. The other one is a Knowledge bank in our portal where the Knowledge such as new technology, Standards, Design calculations, Benchmark data, learning from RCA/CA can be shared. We even went to an extent of doing FMEA for the latter. Significantly, we have created a separate function to manage these Knowledge Management Programs.

As for the effectiveness measurement of these initiatives, we have not reached that far but inputs from this thread and other sources should help. But it's like sowing a seed, if only the Top Management nurtures it, you get there apples in due course. A typical Top Management would normally under estimate the value of initiatives such as these as much as they do with Training programs, just because they don't show a tangible short-term result.

indeed the processes suggested are more aligned towards respective systems.(would be in place 1 form/motive or other)

What does it to take to differentiate/appreciate the mere "initiatie"---> "Value" / "Culture" or even leveraging the expertize.;
i was wondering if there is some integrated-approach required to institutionalize and drive the value both ways. (current/existing processes and future direction)
 

v9991

Trusted Information Resource
QUALITY BY DESIGN (QbD) IN PHARMACEUTICALS
http://www.ijppsjournal.com/Vol4Issue1/2803.pdf
ABSTRACT
Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile, Designing product and manufacturing processes, Identifying critical quality attributes, process parameters, and sources of variability and controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment. The pharmaceutical industry works hard to develop, manufacture, and bring to market new drugs—and to comply with regulatory requirements to demonstrate that the drugs are safe and effective. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. This article explores the processes used in developing a market formulation and requisite supportive data, particularly in light of the industry’s current movement toward submissions based on quality by design (QbD). The work also clarifies the risk based distinctions governing the assignment of criticality to provide consistency and facilitate the adoption and implementation of Quality by Design (QbD) principles in the development of pharmaceutical manufacturing processes. The application of the concept of quality by design (QbD) presented in this paper aligns with the principles of ICH Q8, Q9 and Q10 guidelines.
 
Top Bottom