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36 BioPharm International ® Quality and Regulatory Sourcebook March eBook 2023 www.biopharminternational.com K nowledge ManageMent 3. European Commission, EudraLex , Volume 4 , EU Guidelines to Good Manufacturing Practice Medici- nal Products for Human and Veterinary Use, Annex 15, Qualification and Validation, October 2015. 4. E M A , N ot ice to Stak eholde r s - Q u es t ion s an d Answers on Regulatory Expectations for Medicinal P roducts for Human Use D ur ing the COV I D -19 Pandemic (April 2020) 5. ISPE, ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition (June 2019) 6. ICH, Q8(R2), Pharmaceutical Development (2009) 7. ICH, Q10, Pharmaceutical Quality System (2008) 8. ICH, Q11 Development and Manufacture of Drug Substances (2012) 9. I C H , Q 1 2 P h a r m a c e u t i c a l P r o d u c t L i f e c y c l e Management (2019) 10. IC H , Q13 Cont inuou s M anufac t ur ing of D r ug Substances and Drug Products (2022) 11. Katz, P; Campbell, C. FDA 2011 Process Validation Guidance: Process Validation Revisited. Journal of GXP Compliance. Fall 2012, 16 (4). 12. Campbell, C. FDA 2011 Process Validation Guid- ance: Lifecycle Compliance Model. PDA Journal of Pharmaceutical Science and Technology. March 2014, 68 (2). 13. C a m b r i d g e , C a m b r i d g e A d v a n c e d L e a r n e r 's Dictionar y, 4t h Edition; Cambridge Universit y Press, Cambridge, Aug. 6, 2013. 14. Dawkins, R. The Tyranny of the Discontinuous Mind, newstateman.com, Dec. 19, 2011. 15. Ichikawa, J.J.; Steup, M. The Analysis of Knowledge. In Stanford Encyclopaedia of Philosophy. Summer 2019. Zalta, E.N. Ed. Metaphysics Research Lab, Stanford University. ■ Curia .......................................................................................................... 3 Entegris.................................................................................................... 15 G-CON Manufacturing ........................................................................... 31 Ad Index COMPANY PAGE Appendix: DNA as The Basis of International Council for Harmonisation (ICH) Q9(R1) and ICH Q10 Integration DNA is a long polymer made from repeating units called nucleotides. The structure of DNA is dynamic along its length, capable of coiling into tight loops and other shapes. In all species it is composed of two helical chains, bound to each other by hydrogen bonds. QKR is DNA's Manufacturing Equivalent Quality:Knowledge:Risk (QKR) is a configurable knowledge management (KM) category based on the structure of the DNA double helix. It is designed to facilitate integrated and accelerated implementation of the ICH Q9(R1) and ICH Q10 guidelines. Interdisciplinary QKR building blocks can be applied to new and existing manufacturing systems and pro- cesses, regardless of type, complexity or scale. As is the case for DNA, QKR integrity is a function of time, and this, along with shelf-life and ICH Q12 lifecycle criteria, can be managed by the addition of a suffix to its identifier (e.g., QKR 0,1 @t). The instantaneous QKR model, with DNA as its prototype, challenges conventional industry wisdom, and org charts, that assume that quality management, risk management, and knowledge management are complementary but separate aspects and stages of the product lifecycle, under the control of assigned specialists with independent skillsets. This worldview is a legacy of a pre-pandemic product delivery environment, and incompatible with today's urgent and fast- track manufacturing and inspectional norms. The author's recommendation is that informed general practitioners (GPs) trump subject matter experts (SMEs) in the delivery and oversight of QKR. TABLE. Examples. ICH Q9 (R1) & ICH Q10 integration Example 1 Example 2 Example 3 Example 4 Q Strand #1 Quality Accuracy Smoothness Purity Stability K Connector Knowledge Accurate Smooth Pure Stable R Strand #2 Risk Inaccuracy Roughness Impurity Instability Note 1: Knowledge equates to evidence, captured or referenced initially via risk-based qualification and training, and subsequently by ongoing monitoring and process improvement etc. Note 2: Q = ∑q, K = ∑k, R = ∑r (where ∑ denotes the 'sum of').