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머리말​

  1. Rathore AS, Winkle H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology 27(1):26-34. https://doi.org/10.1038/nbt0109-26
  2. FDA (U.S. Food and Drug Administration). (2004). Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. FDA, CDER/CVM/ORA, September 2004. https://www.fda.gov/media/71012/download
  3. Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data 3:160018. https://doi.org/10.1038/sdata.2016.18

1장 — 바이오의약품과 그 데이터 그림자​

  1. Rathore AS, Winkle H. (2009). Quality by design for biopharmaceuticals. Nature Biotechnology 27(1):26-34. https://doi.org/10.1038/nbt0109-26
  2. ICH (International Council for Harmonisation). (2009). ICH Harmonised Tripartite Guideline Q8(R2): Pharmaceutical Development. ICH, Current Step 4 version, August 2009. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
  3. FDA (U.S. Food and Drug Administration). (2004). Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. FDA, CDER/CVM/ORA, September 2004. https://www.fda.gov/media/71012/download
  4. FDA (U.S. Food and Drug Administration). (2024). 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals. U.S. Code of Federal Regulations, Title 21, Chapter I, Subchapter C, Part 211 (Subpart J, Records and Reports). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
  5. FDA (U.S. Food and Drug Administration). (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers - Guidance for Industry. FDA, CDER/CBER/CVM, December 2018, Docket FDA-2018-D-3984. https://www.fda.gov/media/119267/download
  6. FDA (U.S. Food and Drug Administration). (1997). 21 CFR Part 11 - Electronic Records; Electronic Signatures. U.S. Code of Federal Regulations, Title 21, Chapter I, Subchapter A, Part 11 (Final Rule, Federal Register 62(54):13430-13466). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
  7. Banner M, Alosert H, Spencer C, Cheeks M, Farid SS, Thomas M, Goldrick S. (2021). A decade in review: use of data analytics within the biopharmaceutical sector. Current Opinion in Chemical Engineering 34:100758. https://doi.org/10.1016/j.coche.2021.100758
  8. Narayanan H, Luna MF, von Stosch M, Cruz Bournazou MN, Polotti G, Morbidelli M, Butte A, Sokolov M. (2020). Bioprocessing in the Digital Age: The Role of Process Models. Biotechnology Journal 15(1):e1900172. https://doi.org/10.1002/biot.201900172
  9. CMC Biotech Working Group. (2009). A-Mab: A Case Study in Bioprocess Development (Version 2.1). CASSS / ISPE, Emeryville, CA. https://www.casss.org/papers-and-presentations/resource/a-mab-a-case-study-in-bioprocess-development
  10. ISPE (International Society for Pharmaceutical Engineering). (2022). GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). ISPE, Second Edition, July 2022. https://guidance-docs.ispe.org/doi/book/10.1002/9781946964571

2장 — 데이터 한 점의 생애주기​

  1. MHRA (Medicines and Healthcare products Regulatory Agency). (2018). 'GXP' Data Integrity Guidance and Definitions, Revision 1. Medicines and Healthcare products Regulatory Agency (UK), March 2018. https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
  2. WHO (World Health Organization), Expert Committee on Specifications for Pharmaceutical Preparations. (2021). Guideline on Data Integrity (Annex 4). WHO Technical Report Series No. 1033, 55th report, Annex 4. https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf
  3. PIC/S (Pharmaceutical Inspection Co-operation Scheme). (2021). Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). Pharmaceutical Inspection Co-operation Scheme, PI 041-1, 1 July 2021, 63 pp. https://picscheme.org/docview/4234
  4. FDA (U.S. Food and Drug Administration). (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers — Guidance for Industry. U.S. FDA / CDER / CBER / CVM, Final guidance, December 2018, Docket FDA-2018-D-3984. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
  5. ISPE (International Society for Pharmaceutical Engineering), GAMP Community of Practice. (2017). ISPE GAMP Guide: Records and Data Integrity. International Society for Pharmaceutical Engineering (ISPE), March 2017. https://ispe.org/publications/guidance-documents/gamp-records-pharmaceutical-data-integrity
  6. McDowall, R. D. (2018). Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories. The Royal Society of Chemistry, 598 pp. (Ch. 9 'An Analytical Data Life Cycle'; Ch. 18 'Record Retention'). https://doi.org/10.1039/9781788013277
  7. DAMA International. (2017). DAMA-DMBOK: Data Management Body of Knowledge, 2nd Edition. Technics Publications, 590 pp., ISBN 978-1-63462-234-9. https://technicspub.com/dmbok2/
  8. Kavasidis, I.; Lallas, E.; Leligkou, H. C.; Oikonomidis, G.; Karydas, D.; Gerogiannis, V. C.; Karageorgos, A. (2023). Deep Transformers for Computing and Predicting ALCOA+ Data Integrity Compliance in the Pharmaceutical Industry. Applied Sciences, 13(13):7616. https://doi.org/10.3390/app13137616

3장 — 공정 데이터가 태어나는 곳들​

  1. Rathore AS, Bhambure R, Ghare V. (2010). Process analytical technology (PAT) for biopharmaceutical products. Analytical and Bioanalytical Chemistry 398(1):137-154. https://doi.org/10.1007/s00216-010-3781-x
  2. Glassey J, Gernaey KV, Clemens C, Schulz TW, Oliveira R, Striedner G, Mandenius C-F. (2011). Process analytical technology (PAT) for biopharmaceuticals. Biotechnology Journal 6(4):369-377. https://doi.org/10.1002/biot.201000356
  3. Konstantinov KB, Cooney CL. (2015). White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium. Journal of Pharmaceutical Sciences 104(3):813-820. https://doi.org/10.1002/jps.24268
  4. Abu-Absi NR, Kenty BM, Cuellar ME, Borys MC, Sakhamuri S, Strachan DJ, Hausladen MC, Li ZJ. (2011). Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe. Biotechnology and Bioengineering 108(5):1215-1221. https://doi.org/10.1002/bit.23023
  5. Rathore AS, Parr L, Dermawan S, Lawson K, Lu Y. (2010). Large scale demonstration of a process analytical technology application in bioprocessing: use of on-line high performance liquid chromatography for making real time pooling decisions for process chromatography. Biotechnology Progress 26(2):448-457. https://doi.org/10.1002/btpr.320
  6. Luttmann R, Bracewell DG, Cornelissen G, Gernaey KV, Glassey J, Hass VC, Kaiser C, Preusse C, Striedner G, Mandenius C-F. (2012). Soft sensors in bioprocessing: a status report and recommendations. Biotechnology Journal 7(8):1040-1048. https://doi.org/10.1002/biot.201100506
  7. Lee SL, O'Connor TF, Yang X, Cruz CN, Chatterjee S, Madurawe RD, Moore CMV, Yu LX, Woodcock J. (2015). Modernizing pharmaceutical manufacturing: from batch to continuous production. Journal of Pharmaceutical Innovation 10(3):191-199. https://doi.org/10.1007/s12247-015-9215-8
  8. FDA (U.S. Food and Drug Administration, CDER/CVM/ORA). (2004). Guidance for Industry. PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Department of Health and Human Services, FDA, Rockville, MD (Sept. 2004). https://www.fda.gov/media/71012/download

4장 — 데이터 소스로서의 계측기와 센서​

  1. US FDA (CDER, CVM, ORA). (2004). Guidance for Industry — PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. Food and Drug Administration, Rockville, MD (Docket FDA-2003-D-0032). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance
  2. Rathore AS, Bhambure R, Ghare V. (2010). Process analytical technology (PAT) for biopharmaceutical products. Analytical and Bioanalytical Chemistry 398(1):137-154. https://doi.org/10.1007/s00216-010-3781-x
  3. Lourenço ND, Lopes JA, Almeida CF, Sarraguça MC, Pinheiro HM. (2012). Bioreactor monitoring with spectroscopy and chemometrics: a review. Analytical and Bioanalytical Chemistry 404(4):1211-1237. https://doi.org/10.1007/s00216-012-6073-9
  4. Abu-Absi NR, Kenty BM, Cuellar ME, Borys MC, Sakhamuri S, Strachan DJ, Hausladen MC, Li ZJ. (2011). Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe. Biotechnology and Bioengineering 108(5):1215-1221. https://doi.org/10.1002/bit.23023
  5. Esmonde-White KA, Cuellar M, Uerpmann C, Lenain B, Lewis IR. (2017). Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing. Analytical and Bioanalytical Chemistry 409(3):637-649. https://doi.org/10.1007/s00216-016-9824-1
  6. Esmonde-White KA, Cuellar M, Lewis IR. (2022). The role of Raman spectroscopy in biopharmaceuticals from development to manufacturing. Analytical and Bioanalytical Chemistry 414(2):969-991. https://doi.org/10.1007/s00216-021-03727-4
  7. Claßen J, Aupert F, Reardon KF, Solle D, Scheper T. (2017). Spectroscopic sensors for in-line bioprocess monitoring in research and pharmaceutical industrial application. Analytical and Bioanalytical Chemistry 409(3):651-666. https://doi.org/10.1007/s00216-016-0068-x
  8. ICH. (2023). ICH Q14: Analytical Procedure Development. International Council for Harmonisation, Step 4 (adopted 1 Nov 2023). https://database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1116.pdf
  9. Rogers RS, Nightlinger NS, Livingston B, Campbell P, Bailey R, Balland A. (2015). Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics. mAbs 7(5):881-890. https://doi.org/10.1080/19420862.2015.1069454

5장 — 자동화와 공정 제어 데이터​

  1. International Society of Automation (ISA); ANSI. (2010). ANSI/ISA-88.00.01-2010, Batch Control Part 1: Models and Terminology. International Society of Automation (ISA), Research Triangle Park, NC. https://www.isa.org/products/isa-88-00-01-2010-batch-control-part-1-models
  2. International Society of Automation (ISA); ANSI. (2025). ANSI/ISA-95.00.01-2025 (IEC 62264-1 Mod), Enterprise-Control System Integration Part 1: Models and Terminology. International Society of Automation (ISA), Research Triangle Park, NC. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
  3. International Electrotechnical Commission (IEC); ISO. (2013). IEC 62264-1:2013, Enterprise-control system integration - Part 1: Models and terminology (Edition 2.0). International Electrotechnical Commission (IEC), Geneva, jointly with ISO TC184/SC5. https://www.iso.org/standard/57308.html
  4. NAMUR (User Association of Automation Technology in Process Industries). (2003). NAMUR NE 33: Requirements to be met by Systems for Recipe-Based Operations. NAMUR, Leverkusen, Germany (Recommendation NE 033, dated 2003-01-17). https://www.namur.net/en/work-areas-and-project-groups/wa-2-automation-systems-for-processes-and-plants/wg-23-batch-control.html
  5. International Society of Automation (ISA); ANSI. (2016). ANSI/ISA-18.2-2016, Management of Alarm Systems for the Process Industries. International Society of Automation (ISA), Research Triangle Park, NC. https://www.isa.org/products/ansi-isa-18-2-2016-management-of-alarm-systems-for
  6. International Electrotechnical Commission (IEC). (2025). IEC 61131-3:2025, Programmable controllers - Part 3: Programming languages (Edition 4.0). International Electrotechnical Commission (IEC), Geneva (TC65/SC65B). https://webstore.iec.ch/en/publication/68533
  7. Godena G., Lukman T., Steiner I., Bergant F., Strmcnik S. (2015). A new object model of batch equipment and procedural control for better recipe reuse. Computers in Industry, 70:46-55. https://doi.org/10.1016/j.compind.2015.02.002
  8. U.S. Food and Drug Administration (FDA). (2003). Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Application. U.S. FDA, Center for Drug Evaluation and Research (Docket FDA-2003-D-0143). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  9. U.S. Food and Drug Administration (FDA). (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers - Guidance for Industry. U.S. FDA, CDER/CBER/CVM (finalized December 2018; Docket FDA-2018-D-3984). https://www.fda.gov/media/119267/download

6장 — 공장 정보 시스템: 히스토리안, MES, LIMS, ELN​

  1. International Society of Automation (ISA). (2025). ANSI/ISA-95.00.01-2025 (IEC 62264-1 Mod), Enterprise-Control System Integration - Part 1: Models and Terminology. International Society of Automation (ISA); modified adoption of IEC 62264-1. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
  2. Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data, 3:160018. https://doi.org/10.1038/sdata.2016.18
  3. International Society for Pharmaceutical Engineering (ISPE). (2023). ISPE Baseline Guide Volume 8: Pharma 4.0 (First Edition). International Society for Pharmaceutical Engineering (ISPE); Baseline Guide Vol. 8, December 2023. https://guidance-docs.ispe.org/doi/book/10.1002/9781946964724
  4. US Food and Drug Administration (FDA). (1997). 21 CFR Part 11 - Electronic Records; Electronic Signatures (Final Rule). US Code of Federal Regulations, Title 21, Part 11; Final Rule 62 FR 13430, 20 March 1997. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
  5. US Food and Drug Administration (FDA). (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers - Guidance for Industry. US FDA, CDER/CBER/CVM; Docket FDA-2018-D-3984 (Final, December 2018). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
  6. International Society for Pharmaceutical Engineering (ISPE). (2022). GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). International Society for Pharmaceutical Engineering (ISPE); GAMP 5 Guide, 2nd Edition, July 2022. https://guidance-docs.ispe.org/doi/book/10.1002/9781946964571
  7. International Electrotechnical Commission (IEC). (2020). IEC TR 62541-1:2020, OPC Unified Architecture - Part 1: Overview and concepts. International Electrotechnical Commission, Geneva; IEC 62541 series (OPC UA), Part 1 of the multi-part standard. https://webstore.iec.ch/publication/61109
  8. Pharmaceutical Inspection Co-operation Scheme (PIC/S). (2021). Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). Pharmaceutical Inspection Co-operation Scheme (PIC/S), Geneva; PI 041-1, in force 1 July 2021. https://picscheme.org/docview/4234
  9. Chen Y, Yang O, Sampat C, Bhalode P, Ramachandran R, Ierapetritou M. (2020). Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review. Processes, 8(9):1088. https://doi.org/10.3390/pr8091088

7장 — 아키텍처와 통합: ISA-95, OT/IT, 그리고 엣지-투-클라우드​

  1. Williams TJ. (1994). The Purdue Enterprise Reference Architecture. Computers in Industry 24(2-3):141-158. https://doi.org/10.1016/0166-3615(94)90017-5
  2. International Society of Automation (ISA). (2025). ANSI/ISA-95.00.01-2025 (IEC 62264-1 Mod), Enterprise-Control System Integration - Part 1: Models and Terminology. International Society of Automation, Research Triangle Park, NC; standard ANSI/ISA-95.00.01-2025. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
  3. Stouffer K, Pease M, Tang C, Zimmerman T, Pillitteri V, Lightman S, Hahn A, Saravia S, Sherule A, Thompson M. (2023). Guide to Operational Technology (OT) Security. NIST Special Publication 800-82 Revision 3, National Institute of Standards and Technology. https://doi.org/10.6028/NIST.SP.800-82r3
  4. International Electrotechnical Commission (IEC) / ISA99 committee. (2013). IEC 62443-3-3: Industrial communication networks - Network and system security - Part 3-3: System security requirements and security levels. International Electrotechnical Commission, Geneva; standard IEC 62443-3-3:2013. https://webstore.iec.ch/publication/7033
  5. Venanzi R, Di Modica G, Foschini L, Bellavista P. (2025). Towards IT/OT integration in industry digitalization: A comprehensive survey. Journal of Network and Computer Applications 245:104373. https://doi.org/10.1016/j.jnca.2025.104373
  6. Eclipse Sparkplug Working Group, Eclipse Foundation. (2022). Sparkplug Specification Version 3.0.0 (MQTT Topic Namespace and Payload Definition for Industrial IoT). Eclipse Foundation Specification Process, ratified 21 Oct 2022. https://sparkplug.eclipse.org/specification/version/3.0/
  7. International Electrotechnical Commission (IEC) / ANSI-ISA. (1997). IEC 61512-1 (ANSI/ISA-88.01): Batch control - Part 1: Models and terminology. International Electrotechnical Commission, Geneva; standard IEC 61512-1:1997. https://webstore.iec.ch/publication/5528
  8. European Commission (EudraLex Volume 4, EU GMP). (2011). EudraLex Volume 4, Good Manufacturing Practice, Annex 11: Computerised Systems. European Commission, Health and Consumers Directorate-General; EudraLex Volume 4 GMP Guidelines. https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf

8장 — 연결성과 상호운용성 표준​

  1. IEC (International Electrotechnical Commission). (2025). IEC 62541-1:2025 OPC Unified Architecture - Part 1: Overview and concepts. International Electrotechnical Commission, Geneva; IEC 62541-1:2025 (International Standard, Ed. 1.0, supersedes IEC TR 62541-1:2020). https://webstore.iec.ch/en/publication/81513
  2. VDI/VDE/NAMUR (Verein Deutscher Ingenieure / VDE / NAMUR). (2019). VDI/VDE/NAMUR 2658 Part 1: Automation engineering of modular systems in the process industry - General concept and interfaces. VDI-Gesellschaft Mess- und Automatisierungstechnik, Beuth/DIN Media, Berlin; VDI/VDE/NAMUR 2658 Blatt 1:2019-10. https://www.vdi.de/en/home/vdi-standards/details/vdivdenamur-2658-blatt-1-automation-engineering-of-modular-systems-in-the-process-industry-general-concept-and-interfaces
  3. Juchli, D. (2022). SiLA 2: The Next Generation Lab Automation Standard. In: Beutel S., Lenk F. (eds), Smart Biolabs of the Future, Advances in Biochemical Engineering/Biotechnology, vol 182, pp. 147-174, Springer, Cham. https://doi.org/10.1007/10_2022_204
  4. Kayser, H.; Lau, M.-L. (2024). Growing value of data standardization: Allotrope Foundation Connect Workshop Proceedings. Drug Discovery Today, 29(6):103988. https://doi.org/10.1016/j.drudis.2024.103988
  5. Schäfer, B. A.; Poetz, D.; Kramer, G. W. (2004). Documenting Laboratory Workflows Using the Analytical Information Markup Language. Journal of the Association for Laboratory Automation (JALA), 9(6):375-381. https://doi.org/10.1016/j.jala.2004.10.003
  6. ASTM International. (2024). ASTM E2078-00(2024) Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data (with ASTM E2077-00(2024) Standard Specification). ASTM International, West Conshohocken, PA; E2078-00(2024) and E2077-00(2024). https://www.astm.org/e2078-00r24.html
  7. ISA (International Society of Automation) / IEC. (2025). ANSI/ISA-95.00.01-2025 (IEC 62264-1 Mod) Enterprise-Control System Integration - Part 1: Models and Terminology. International Society of Automation, Research Triangle Park, NC; ANSI/ISA-95.00.01-2025 / IEC 62264-1 Mod. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
  8. Celebi, I.; Dragoset, R. A.; Olsen, K. J.; Schaefer, R.; Kramer, G. W. (2010). Improving Interoperability by Incorporating UnitsML Into Markup Languages. Journal of Research of the National Institute of Standards and Technology, 115(1):15-22. https://doi.org/10.6028/jres.115.003
  9. Freitas, L.; Pereira, F.; Lopes, H.; Lima, A.; Marujo, P.; Ottaviano, E.; Machado, J. (2024). OPC-UA in interoperability - a performance comparative testing. IFAC-PapersOnLine, 58(8):240-245. https://doi.org/10.1016/j.ifacol.2024.08.127

9장 — 데이터 무결성과 ALCOA+​

  1. U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers — Guidance for Industry. FDA, CDER (Final Guidance, December 2018), Docket FDA-2018-D-3984. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
  2. Medicines and Healthcare products Regulatory Agency (MHRA). (2018). 'GXP' Data Integrity Guidance and Definitions, Revision 1. MHRA, UK (March 2018), 21 pp. https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
  3. Pharmaceutical Inspection Co-operation Scheme (PIC/S). (2021). Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). PIC/S, Geneva, PI 041-1, 1 July 2021, 63 pp. https://picscheme.org/docview/4234
  4. World Health Organization (WHO). (2021). Guideline on Data Integrity (Annex 4, WHO Technical Report Series No. 1033). WHO Expert Committee on Specifications for Pharmaceutical Preparations, 55th report, TRS 1033, Annex 4. https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf
  5. European Medicines Agency (EMA), GMP/GDP Inspectors Working Group. (2016). Questions and Answers: Good Manufacturing Practice — Data Integrity. EMA GMP/GDP Compliance Q&As (23 questions on data integrity and the data life cycle). https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers
  6. International Society for Pharmaceutical Engineering (ISPE), GAMP Community of Practice. (2017). ISPE GAMP Guide: Records and Data Integrity. ISPE (March 2017), 152 pp. https://guidance-docs.ispe.org/doi/book/10.1002/9781936379965
  7. McDowall RD. (2018). Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories. Royal Society of Chemistry, Cambridge; ISBN 978-1-78801-281-2. https://doi.org/10.1039/9781788013277
  8. Woollen SW. (2010). Data Quality and the Origin of ALCOA. The Compass, Summer 2010, Newsletter of the Southern Regional Chapter, Society of Quality Assurance. https://rx-360.org/wp-content/uploads/2018/08/Data-Quality-and-the-Origin-of-ALCOA-by-Stan-Woolen-2010.pdf

10장 — 기록, 서명, 그리고 법: 21 CFR Part 11과 EU Annex 11​

  1. FDA (US Food and Drug Administration). (1997). Electronic Records; Electronic Signatures; Final Rule (21 CFR Part 11). Federal Register, 62(54):13430-13466; Docket No. 92N-0251; FR Doc. 97-6833. https://www.federalregister.gov/documents/1997/03/20/97-6833/electronic-records-electronic-signatures
  2. FDA (CDER, CBER, CDRH, CFSAN, CVM, ORA). (2003). Guidance for Industry — Part 11, Electronic Records; Electronic Signatures — Scope and Application. U.S. Food and Drug Administration; Docket No. FDA-2003-D-0143 (announced Federal Register 68 FR, 05 Sep 2003, FR Doc. 03-22574). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  3. European Commission (EudraLex Volume 4 GMP). (2011). EudraLex — The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Annex 11: Computerised Systems. European Commission, Health and Consumers Directorate-General; effective 30 June 2011. https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf
  4. ISPE (International Society for Pharmaceutical Engineering). (2022). GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). ISPE, North Bethesda, MD (Second Edition). https://guidance-docs.ispe.org/doi/book/10.1002/9781946964571
  5. MHRA (Medicines and Healthcare products Regulatory Agency). (2018). 'GXP' Data Integrity Guidance and Definitions, Revision 1. UK Medicines and Healthcare products Regulatory Agency, March 2018. https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
  6. PIC/S (Pharmaceutical Inspection Co-operation Scheme). (2021). Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). Pharmaceutical Inspection Co-operation Scheme, PI 041-1, entered into force 1 July 2021. https://picscheme.org/docview/4234
  7. FDA (CDER, CBER, CVM). (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers — Guidance for Industry. U.S. Food and Drug Administration; Docket No. FDA-2018-D-3984 (Federal Register 13 Dec 2018, FR Doc. 2018-26957). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
  8. WHO Expert Committee on Specifications for Pharmaceutical Preparations. (2016). Guidance on Good Data and Record Management Practices (Annex 5, WHO Technical Report Series No. 996). World Health Organization, WHO Technical Report Series No. 996, Annex 5, 2016. https://www.who.int/publications/i/item/WHO_TRS_996
  9. Bansal A, Chamberlain R, Karr S, Kwasa S, McLaughlin B, Nguyen B, Rendell M, Schmit K, Smith C. (2012). A 21 CFR Part 11 Compliant Graphically Based Electronic System for Clinical Research Documentation. Journal of Medical Systems, 36(3):1661-1672. https://doi.org/10.1007/s10916-010-9627-4

11장 — 전산화 시스템 검증: GAMP 5와 CSA로의 전환​

  1. ISPE (International Society for Pharmaceutical Engineering). (2022). ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). ISPE, Tampa, FL. https://guidance-docs.ispe.org/doi/book/10.1002/9781946964571
  2. U.S. Food and Drug Administration (CDRH, CBER). (2025). Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff. U.S. FDA; Federal Register notice 90 FR (24 Sep 2025), Docket FDA-2022-D-0795; finalizes the 13 Sep 2022 draft. https://www.federalregister.gov/documents/2025/09/24/2025-18468/computer-software-assurance-for-production-and-quality-system-software-guidance-for-industry-and
  3. U.S. Food and Drug Administration (CDRH, CBER). (2022). Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. Federal Register 87 FR 56043 (13 Sep 2022), Docket FDA-2022-D-0795. https://www.federalregister.gov/documents/2022/09/13/2022-19763/computer-software-assurance-for-production-and-quality-system-software-draft-guidance-for-industry
  4. ASTM International (Committee E55). (2025). ASTM E2500-25 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach. ASTM International, West Conshohocken, PA; revision supersedes E2500-20. https://store.astm.org/e2500-25.html
  5. ICH (International Council for Harmonisation). (2023). ICH Harmonised Guideline Q9(R1): Quality Risk Management. ICH; Step 4 adopted 18 Jan 2023 (Step 4 document dated 2022-12-19). https://database.ich.org/sites/default/files/ICH_Q9(R1)_Guideline_Step4_2022_1219.pdf
  6. U.S. Food and Drug Administration (CDRH, CBER). (2002). General Principles of Software Validation; Final Guidance for Industry and FDA Staff. U.S. FDA, issued 11 Jan 2002, Docket No. 97D-0282. https://www.federalregister.gov/documents/2002/01/11/02-690/medical-devices-general-principles-of-software-validation-final-guidance-for-industry-and-fda-staff
  7. European Commission (EudraLex Volume 4, EU GMP). (2011). EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 11: Computerised Systems. European Commission, EudraLex Vol. 4; effective 30 Jun 2011. https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf
  8. U.S. Food and Drug Administration. (1997). 21 CFR Part 11 - Electronic Records; Electronic Signatures (Final Rule). Federal Register 62 FR 13430 (20 Mar 1997), Docket No. 92N-0251; effective 20 Aug 1997. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
  9. Walia, G.; Neri, D. (2024). Computer Software Assurance and the Critical Thinking Approach. Pharmaceutical Engineering (ISPE), March/April 2024. https://ispe.org/pharmaceutical-engineering/march-april-2024/computer-software-assurance-and-critical-thinking

12장 — 데이터 거버넌스, 데이터 품질, 마스터 데이터​

  1. DAMA International. (2017). DAMA-DMBOK: Data Management Body of Knowledge (2nd Edition). Technics Publications, Denville, NJ; ISBN 978-1-634622-34-9. https://technicspub.com/dmbok2/
  2. Wang RY, Strong DM. (1996). Beyond Accuracy: What Data Quality Means to Data Consumers. Journal of Management Information Systems 12(4):5-33. https://doi.org/10.1080/07421222.1996.11518099
  3. Khatri V, Brown CV. (2010). Designing Data Governance. Communications of the ACM 53(1):148-152. https://doi.org/10.1145/1629175.1629210
  4. Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data 3:160018. https://doi.org/10.1038/sdata.2016.18
  5. ISPE (International Society for Pharmaceutical Engineering). (2017). ISPE GAMP Guide: Records and Data Integrity. ISPE, Tampa, FL; ISBN 978-1-936379-96-5. https://guidance-docs.ispe.org/doi/book/10.1002/9781936379965
  6. U.S. Food and Drug Administration. (2018). Data Integrity and Compliance With Drug CGMP: Questions and Answers — Guidance for Industry. FDA, CDER/CBER/CVM; Docket FDA-2018-D-3984. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
  7. Medicines and Healthcare products Regulatory Agency (MHRA). (2018). 'GXP' Data Integrity Guidance and Definitions, Revision 1. MHRA, UK Government (gov.uk). https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
  8. World Health Organization (WHO). (2021). Guideline on data integrity (WHO Technical Report Series No. 1033, Annex 4). WHO Expert Committee on Specifications for Pharmaceutical Preparations, 55th report; WHO, Geneva. https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf
  9. International Organization for Standardization (ISO). (2022). ISO 8000-1:2022 Data quality — Part 1: Overview. ISO, Geneva (ISO/TC 184/SC 4); supersedes ISO/TS 8000-1:2011. https://www.iso.org/standard/81745.html

13장 — 왜 숫자들은 서로 연결되지 않는가: 의미적 상호운용성 문제​

  1. Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data 3:160018. https://doi.org/10.1038/sdata.2016.18
  2. International Electrotechnical Commission (IEC); International Organization for Standardization (ISO) [based on ANSI/ISA-95.00.01-2010]. (2013). IEC 62264-1:2013 Enterprise-control system integration — Part 1: Models and terminology (2nd ed.). IEC/ISO, Geneva (double-logo standard; IEC TC 65/SC 65E with ISO TC 184/SC 5). https://www.iso.org/standard/57308.html
  3. Karray MH, Otte N, Rai R, Ameri F, Kulvatunyou B, Smith B, Kiritsis D, Will C, Arista R. (2021). The Industrial Ontologies Foundry (IOF) perspectives. Proc. I-ESA 2020 IOF 'Achieving Data Interoperability' Workshop, Tarbes, France (NIST pub. 925879). https://www.nist.gov/publications/industrial-ontologies-foundry-iof-perspectives
  4. Drobnjakovic M, Kulvatunyou B, Ameri F, Will C, Smith B, Jones AT. (2022). The Industrial Ontologies Foundry (IOF) Core Ontology. CEUR Workshop Proceedings, vol. 3240 (FOMI 2022, 12th Int. Workshop on Formal Ontologies meet Industry), Tarbes, France. https://ceur-ws.org/Vol-3240/paper3.pdf
  5. Uschold M, Gruninger M. (1996). Ontologies: principles, methods and applications. The Knowledge Engineering Review 11(2):93–136. https://doi.org/10.1017/S0269888900007797
  6. Tolk A, Muguira JA. (2003). The Levels of Conceptual Interoperability Model (LCIM). Proc. 2003 Fall Simulation Interoperability Workshop, Orlando, FL (paper 03F-SIW-007), Simulation Interoperability Standards Organization (SISO), pp. 1–11. https://www.mscoe.org/content/uploads/2017/12/Tolk-Muguira-The-Levels-of-Conceptual-Interoperability-Models.pdf
  7. International Organization for Standardization / International Electrotechnical Commission (ISO/IEC). (2021). ISO/IEC 21838-2:2021 Information technology — Top-level ontologies (TLO) — Part 2: Basic Formal Ontology (BFO). ISO/IEC, Geneva (ISO/IEC JTC 1). https://www.iso.org/standard/74572.html
  8. Kayser H, Lau M-L. (2024). Growing value of data standardization: Allotrope Foundation Connect Workshop Proceedings. Drug Discovery Today 29(6):103988. https://doi.org/10.1016/j.drudis.2024.103988

14장 — 온톨로지와 FAIR 데이터​

  1. Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data 3:160018. https://doi.org/10.1038/sdata.2016.18
  2. Smith B, Ashburner M, Rosse C, et al. (OBI Consortium). (2007). The OBO Foundry: coordinated evolution of ontologies to support biomedical data integration. Nature Biotechnology 25(11):1251-1255. https://doi.org/10.1038/nbt1346
  3. Arp R, Smith B, Spear AD. (2015). Building Ontologies with Basic Formal Ontology. MIT Press, Cambridge, MA (ISBN 9780262527811). https://doi.org/10.7551/mitpress/9780262527811.001.0001
  4. ISO/IEC (Joint Technical Committee JTC 1). (2021). Information technology - Top-level ontologies (TLO) - Part 2: Basic Formal Ontology (BFO). ISO/IEC 21838-2:2021, International Organization for Standardization. https://www.iso.org/standard/74572.html
  5. Drobnjakovic M, Kulvatunyou B, Ameri F, Will C, Smith B, Jones A. (2022). The Industrial Ontologies Foundry (IOF) Core Ontology. Formal Ontologies Meet Industry (FOMI) 2022, CEUR Workshop Proceedings Vol-3240, paper 3. https://ceur-ws.org/Vol-3240/paper3.pdf
  6. Kulvatunyou B, Wallace E, Kiritsis D, Smith B, Will C. (2018). The Industrial Ontologies Foundry Proof-of-Concept Project. Advances in Production Management Systems (APMS 2018), IFIP AICT vol 536, Springer, pp 402-409. https://doi.org/10.1007/978-3-319-99707-0_50
  7. Cyganiak R, Wood D, Lanthaler M (eds.). (2014). RDF 1.1 Concepts and Abstract Syntax. W3C Recommendation, 25 February 2014, World Wide Web Consortium. https://www.w3.org/TR/2014/REC-rdf11-concepts-20140225/
  8. W3C OWL Working Group; Hitzler P, Krötzsch M, Parsia B, Patel-Schneider PF, Rudolph S (eds.). (2012). OWL 2 Web Ontology Language Document Overview (Second Edition). W3C Recommendation, 11 December 2012, World Wide Web Consortium. https://www.w3.org/TR/2012/REC-owl2-overview-20121211/
  9. Knublauch H, Kontokostas D (eds.). (2017). Shapes Constraint Language (SHACL). W3C Recommendation, 20 July 2017, World Wide Web Consortium. https://www.w3.org/TR/shacl/

15장 — 디지털 스레드와 디지털 트윈​

  1. Grieves M, Vickers J. (2017). Digital Twin: Mitigating Unpredictable, Undesirable Emergent Behavior in Complex Systems. In: Kahlen FJ, Flumerfelt S, Alves A (eds), Transdisciplinary Perspectives on Complex Systems: New Findings and Approaches, Springer, Cham, pp. 85-113. https://doi.org/10.1007/978-3-319-38756-7_4
  2. Kritzinger W, Karner M, Traar G, Henjes J, Sihn W. (2018). Digital Twin in manufacturing: A categorical literature review and classification. IFAC-PapersOnLine 51(11):1016-1022 (16th IFAC Symposium INCOM 2018). https://doi.org/10.1016/j.ifacol.2018.08.474
  3. Tao F, Zhang H, Liu A, Nee AYC. (2019). Digital Twin in Industry: State-of-the-Art. IEEE Transactions on Industrial Informatics 15(4):2405-2415. https://doi.org/10.1109/TII.2018.2873186
  4. Udugama IA, Lopez PC, Gargalo CL, Li X, Bayer C, Gernaey KV. (2021). Digital Twin in biomanufacturing: challenges and opportunities towards its implementation. Systems Microbiology and Biomanufacturing 1(3):257-274. https://doi.org/10.1007/s43393-021-00024-0
  5. Sokolov M, von Stosch M, Narayanan H, Feidl F, Butté A. (2021). Hybrid modeling — a key enabler towards realizing digital twins in biopharma?. Current Opinion in Chemical Engineering 34:100715. https://doi.org/10.1016/j.coche.2021.100715
  6. Konstantinov KB, Cooney CL. (2015). White Paper on Continuous Bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium. Journal of Pharmaceutical Sciences 104(3):813-820. https://doi.org/10.1002/jps.24268
  7. International Society of Automation (ISA). (2025). ANSI/ISA-95.00.01-2025 (IEC 62264-1 Mod), Enterprise-Control System Integration — Part 1: Models and Terminology. International Society of Automation; modified adoption of IEC 62264-1 Edition 2. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
  8. ICH (International Council for Harmonisation). (2009). ICH Q8(R2) Pharmaceutical Development. ICH Harmonised Tripartite Guideline (Step 4); EMA ref. EMA/CHMP/ICH/167068/2004. https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline
  9. FDA (U.S. Food and Drug Administration). (2004). Guidance for Industry — PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. U.S. FDA, CDER/CVM/ORA; final guidance issued September 2004 (Federal Register notice 69 FR 59257, Oct 4, 2004). https://www.fda.gov/media/71012/download

16장 — 데이터에서 지식으로: SPC, 다변량 분석, 지속적 공정 검증​

  1. FDA (U.S. Food and Drug Administration), CDER, CBER, CVM. (2011). Guidance for Industry — Process Validation: General Principles and Practices. U.S. Department of Health and Human Services, Food and Drug Administration; Docket No. FDA-2008-D-0559 (Current Good Manufacturing Practices, Revision 1), January 2011. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices
  2. Nomikos P, MacGregor JF. (1995). Multivariate SPC Charts for Monitoring Batch Processes. Technometrics 37(1):41-59. https://doi.org/10.1080/00401706.1995.10485888
  3. Nomikos P, MacGregor JF. (1994). Monitoring Batch Processes Using Multiway Principal Component Analysis. AIChE Journal 40(8):1361-1375. https://doi.org/10.1002/aic.690400809
  4. Kourti T, MacGregor JF. (1995). Process Analysis, Monitoring and Diagnosis, Using Multivariate Projection Methods. Chemometrics and Intelligent Laboratory Systems 28(1):3-21. https://doi.org/10.1016/0169-7439(95)80036-9
  5. MacGregor JF, Kourti T. (1995). Statistical Process Control of Multivariate Processes. Control Engineering Practice 3(3):403-414. https://doi.org/10.1016/0967-0661(95)00014-L
  6. ICH (International Council for Harmonisation). (2008). ICH Q10 Pharmaceutical Quality System. ICH Harmonised Tripartite Guideline (Step 4, June 2008); EMA ref. EMA/CHMP/ICH/214732/2007. https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system-scientific-guideline
  7. Montgomery DC. (2019). Introduction to Statistical Quality Control, 8th Edition. Wiley, Hoboken NJ; ISBN 978-1-119-39930-8. https://www.wiley.com/en-us/Introduction+to+Statistical+Quality+Control,+8th+Edition-p-9781119399308
  8. Woodall WH. (2000). Controversies and Contradictions in Statistical Process Control (with discussion). Journal of Quality Technology 32(4):341-378. https://doi.org/10.1080/00224065.2000.11980013

17장 — 머신러닝, 소프트 센서, 하이브리드 모델​

  1. von Stosch M, Oliveira R, Peres J, Feyo de Azevedo S. (2014). Hybrid semi-parametric modeling in process systems engineering: Past, present and future. Computers & Chemical Engineering 60:86-101. https://doi.org/10.1016/j.compchemeng.2013.08.008
  2. von Stosch M, Davy S, Francois K, Galvanauskas V, Hamelink J-M, Luebbert A, Mayer M, Oliveira R, O'Kennedy R, Rice P, Glassey J. (2014). Hybrid modeling for quality by design and PAT-benefits and challenges of applications in biopharmaceutical industry. Biotechnology Journal 9(6):719-726. https://doi.org/10.1002/biot.201300385
  3. Glassey J, von Stosch M (Eds.). (2018). Hybrid Modeling in Process Industries. CRC Press / Taylor & Francis; ISBN 9781498740869. https://doi.org/10.1201/9781351184373
  4. U.S. Food and Drug Administration (FDA), CDER. (2023). Artificial Intelligence in Drug Manufacturing (Discussion Paper). FDA CDER FRAME Initiative; Docket No. FDA-2023-N-0487. https://www.fda.gov/media/165743/download
  5. Helleckes LM, Hemmerich J, Wiechert W, von Lieres E, Grünberger A. (2023). Machine learning in bioprocess development: from promise to practice. Trends in Biotechnology 41(6):817-835. https://doi.org/10.1016/j.tibtech.2022.10.010
  6. Kadlec P, Gabrys B, Strandt S. (2009). Data-driven Soft Sensors in the process industry. Computers & Chemical Engineering 33(4):795-814. https://doi.org/10.1016/j.compchemeng.2008.12.012
  7. Brunner V, Siegl M, Geier D, Becker T. (2021). Challenges in the Development of Soft Sensors for Bioprocesses: A Critical Review. Frontiers in Bioengineering and Biotechnology 9:722202. https://doi.org/10.3389/fbioe.2021.722202
  8. Narayanan H, Sokolov M, Morbidelli M, Butté A. (2019). A new generation of predictive models: The added value of hybrid models for manufacturing processes of therapeutic proteins. Biotechnology and Bioengineering 116(10):2540-2549. https://doi.org/10.1002/bit.27097
  9. Mowbray M, Savage T, Wu C, Song Z, Cho BA, Del Rio-Chanona EA, Zhang D. (2021). Machine learning for biochemical engineering: A review. Biochemical Engineering Journal 172:108054. https://doi.org/10.1016/j.bej.2021.108054

18장 — 실시간 통합과 Pharma 4.0: 스마트하고 연속적인 공장​

  1. International Council for Harmonisation (ICH). (2023). Q13 Continuous Manufacturing of Drug Substances and Drug Products: Guidance for Industry. U.S. Food and Drug Administration (Docket FDA-2021-D-1047); ICH Harmonised Guideline, Step 4 (endorsed Nov 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q13-continuous-manufacturing-drug-substances-and-drug-products
  2. Konstantinov KB, Cooney CL. (2015). White Paper on Continuous Bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium. Journal of Pharmaceutical Sciences 104(3):813-820. https://doi.org/10.1002/jps.24268
  3. Godawat R, Konstantinov K, Rohani M, Warikoo V. (2015). End-to-end integrated fully continuous production of recombinant monoclonal antibodies. Journal of Biotechnology 213:13-19. https://doi.org/10.1016/j.jbiotec.2015.06.393
  4. International Society for Pharmaceutical Engineering (ISPE). (2023). ISPE Baseline Guide Volume 8: Pharma 4.0 (First Edition). International Society for Pharmaceutical Engineering (ISPE), North Bethesda, MD. https://guidance-docs.ispe.org/doi/book/10.1002/9781946964724
  5. U.S. Food and Drug Administration (FDA), CDER. (2017). Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization: Guidance for Industry. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (Docket FDA-2015-D-4644). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advancement-emerging-technology-applications-pharmaceutical-innovation-and-modernization-guidance
  6. European Medicines Agency (EMA), CHMP/QWP. (2012). Guideline on Real Time Release Testing (formerly Guideline on Parametric Release), Revision 1. European Medicines Agency, EMA/CHMP/QWP/811210/2009 Rev 1 (final 29 Mar 2012; effective 1 Oct 2012). https://www.ema.europa.eu/en/real-time-release-testing-scientific-guideline
  7. International Society of Automation (ISA) / IEC. (2025). ANSI/ISA-95.00.01-2025 (IEC 62264-1 Mod) Enterprise-Control System Integration - Part 1: Models and Terminology. International Society of Automation (ISA), Research Triangle Park, NC; international equivalent IEC 62264-1. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
  8. Chen Y, Yang O, Sampat C, Bhalode P, Ramachandran R, Ierapetritou M. (2020). Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review. Processes 8(9):1088. https://doi.org/10.3390/pr8091088
  9. OAGi; NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals). (2025). OAGi and NIIMBL Announce Release of Biopharmaceutical Manufacturing Ontologies to Advance Interoperability and Analytics. Open Applications Group (OAGi) / NIIMBL, Biopharmaceutical Manufacturing Industry Council (BMIC) within the Industrial Ontologies Foundry (IOF). https://www.niimbl.org/news/oagi-and-niimbl-announce-release-of-biopharmaceutical-manufacturing-ontologies-to-advance-interoperability-and-analytics/

이미지 출처 및 판권​

이 책에 사용된 모든 이미지의 출처와 라이선스입니다. 사진은 명시된 퍼블릭 도메인 또는 크리에이티브 커먼즈(Creative Commons) 조건에 따라 저작자를 표시하여 사용했습니다. CC BY-SA 4.0으로 표시된 두 이미지는 전체 라이선스 링크와 함께 수정 없이(unmodified) 사용했으며, 동일조건변경허락(share-alike) 의무는 해당 이미지와 그 2차적 저작물에만 적용되고 이 책 전체에 적용되지는 않습니다(수집저작물로서의 사용). “저자 원본 도해(Original diagram by the authors)”로 표시된 도식은 모두 저자가 AI의 보조를 받아 직접 제작했으며, 출처를 표시하면 복제·재사용할 수 있습니다. 상업적 인쇄 출판 전 최종 법무 검토를 권장합니다.

  • “One process, two products”. Original diagram by the authors, created with AI assistance.
  • Filled vials of drug product. Image by CSIRO, CC BY 3.0, via Wikimedia Commons.
  • “The data shadow of a single batch”. Original diagram by the authors, created with AI assistance.
  • Fed-batch sampling. Image by Luis Fernando Flores LAB, licensed under CC BY-SA 4.0 (https://creativecommons.org/licenses/by-sa/4.0/), via Wikimedia Commons; used unmodified.
  • Bench-scale bioreactor. Image by Jonas Schenk, released into the public domain, via Wikimedia Commons.
  • Process chromatography skid. Image by Kitmondo Lab, CC BY 2.0, via Wikimedia Commons.
  • “What batch genealogy looks like in data”. Original diagram by the authors, created with AI assistance.
  • Industrial bioreactor schematic. Image by NIST (U.S. government work, public domain), via Wikimedia Commons.
  • Laboratory centrifuge. Image by Ivangiesen, CC0 (public-domain dedication), via Wikimedia Commons.
  • “How control systems create data”. Original diagram by the authors, created with AI assistance.
  • Laminar-flow cabinet. Image by syed sajidul islam, licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/), via Wikimedia Commons; used unmodified.
  • “The plant information-system constellation”. Original diagram by the authors, created with AI assistance.
  • Integrated USP/DSP plant. Image by CC1984USA, licensed under CC BY-SA 4.0 (https://creativecommons.org/licenses/by-sa/4.0/), via Wikimedia Commons; used unmodified.
  • “The ISA-95 / Purdue automation hierarchy”. Original diagram by the authors, created with AI assistance.
  • “Where each connectivity standard lives”. Original diagram by the authors, created with AI assistance.
  • Cleanroom (illustrative; not biopharma-specific). Image by UCL Mathematical and Physical Sciences, CC BY 2.0, via Wikimedia Commons.
  • “How Part 11 and Annex 11 sit atop the predicate rules”. Original diagram by the authors, created with AI assistance.
  • “CSA: risk-proportionate testing”. Original diagram by the authors, created with AI assistance.
  • “A master-data governance lifecycle”. Original diagram by the authors, created with AI assistance.
  • “Pairwise mappings vs one shared model”. Original diagram by the authors, created with AI assistance.
  • “From heterogeneity to FAIR through an ontology”. Original diagram by the authors, created with AI assistance.
  • “Anatomy of a digital twin”. Original diagram by the authors, created with AI assistance.
  • “From hundreds of variables to two charts”. Original diagram by the authors, created with AI assistance.
  • “Mechanistic, data-driven, and hybrid models”. Original diagram by the authors, created with AI assistance.
  • “A Pharma 4.0 smart factory”. Original diagram by the authors, created with AI assistance.