Proposta de implementação da verificação continuada de processos em medicamentos desenvolvidos por Quality by Design, utilizando a ferramenta 5W2H

1. Agência Nacional de Vigilância Sanitária – Anvisa. Resolução RDC Nº 658, de 30 de março de 2022. Dispõe sobre as diretrizes gerais de boas práticas de fabricação de medicamentos. Diário Oficial União. 31 mar 2022. 2. Agência Nacional de Vigilância Sanitária – Anvisa. Instrução normativa Nº 138, de 30 de março de 2022. Dispõe sobre as boas práticas de fabricação complementares às atividades de qualificação e validação. Diário Oficial União. 31 mar 2022. 3. US Food and Drug Administration – FDA. Guidance for industry PAT: process validation: general principles and practices. Silver Spring: US Food and Drug Administration; 2011. 4. Sumeet S, Gurpreet S. Process validation in pharmaceutical industry: an overview. J Drug Delivery Ther. 2013;3(4):184-8.https://doi.org/10.22270/jddt.v3i4.582 5. Grangeia HB, Silva C, Simões SP, Reis MS. Quality by design in pharmaceutical manufacturing: a systematic review of current status, challenges and future perspectives. Eur J Pharm Biopharm. 2020;147:19-37.https://doi.org/10.1016/j.ejpb.2019.12.007 6. Nasr AM, Qushawy MK, Elkhoudary MM, Gawish AY, Elhady SS, Swidan SA et al. Quality by design for the development and analysis of enhanced in-situ forming vesicles for the improvement of the bioavailability of fexofenadine HCl in vitro and in vivo. Pharmaceutics. 2020;12(5):1-22.https://doi.org/10.3390/pharmaceutics12050409 7. Bezerra M, Rodrigues LNC. Quality by design (QbD) como ferramenta para otimização dos processos farmacêuticos. Infarm Cienc Farm. 2017;29(1):5-12.https://doi.org/10.14450/2318-9312.v29.e1.a2017.pp5-12 8. European Medicines Agency – EMA. ICH Q8 (R2) pharmaceutical development: scientific guideline. Amsterdam: European Medicines Agency; 2009. 9. Klingstam P, Olsson BG. December. Using simulation techniques for continuous process verification in industrial system development. In: Joines JA, Barton RR, Kang K, Fishwick PA, editores. 2000 winter simulation conference proceedings. Vol. 2. Piscataway: Institute of Electrical and Electronics Engineers; 2000. p. 1315-21. 10. Parenteral Drug Administration – PDA. Task force on technical report Nº 60: process validation: a lifecycle approach. Bethesda: Parenteral Drug Administration;2013[acesso 10 ago 2024]. Disponível em: https://store.pda.org/TableOfContents/TR6013_TOC.pdf 11. Bernard S. Why product lifecycle management fails pharma: time for a rethink? Pharm Exec J. 2013;1(1):25-8[acesso 10 ago 2024]. Disponível em:https://bernardassociatesllc.com/wp-content/uploads/2013/08/PE_Drug-Life-Optimization_StanBernard2.pdf 12. European Medicines Agency – EMA. ICH guideline Q10 on pharmaceutical quality system. Amsterdam: European Medicines Agency; 2008. 13. European Medicines Agency – EMA. ICH guideline Q9 (R1) on quality risk management. Amsterdam: European Medicines Agency; 2021. 14. European Medicines Agency – EMA. ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management. Amsterdam: European Medicines Agency; 2020. 15. Pazhayattil AB. Continued process verification: reacting to data signals. Bethesda: Parenteral Drug Association; 2020. 16. Pallagi E, Ismail R, Csoka I. Initial risk assessment as part of the quality by design in peptide drug-containing formulation development. Eur J Pharm Sci. 2018;122:160-9.https://doi.org/10.1016/j.ejps.2018.07.003 17. Cunha S, Costa CP, Moreira JN, Lobo JMS, Silva AC. Using the quality by design (QbD) approach to optimize formulations of lipid nanoparticles and nanoemulsions: a review. Nanomed Nanotech Biol Med. 2020;28:102-206.https://doi.org/10.1016/j.nano.2020.102206 18. Fukuda IM, Pinto CFF, Moreira CS, Saviano AM, Lourenço FR. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD). Braz J Pharm Sci. 2018;54(spe):1-16.https://doi.org/10.1590/s2175-97902018000001006 19. Mishra V, Thakur S, Patil A, Shukla A. Quality by design (QbD) approaches in current pharmaceutical set-up. Expert Opin Drug Deliv. 2018;15(8):737-58.https://doi.org/10.1080/17425247.2018.1504768 20. Djuris J, Djuric Z. Modeling in the quality by design environment: regulatory requirements and recommendations for design space and control strategy appointment. Int J Pharm. 2017;533(2);346-56.https://doi.org/10.1016/j.ijpharm.2017.05.070 21. Parshuramkar P, Khobragade D, Kashyap P. Comprehension of quality by design in the development of oral solid dosage forms. J Young Pharm. 2023;15(3):406-18.https://doi.org/10.5530/jyp.2023.15.56 22. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16(4):959-63.https://doi.org/10.1208/s12248-014-9598-3 23. Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: regulatory need. Arab J Chem. 2017;10(6):S3412-25.https://doi.org/10.1016/j.arabjc.2014.01.025 24. Peltonen L. Design space and QbD approach for production of drug nanocrystals by wet media milling techniques. Pharmaceutics. 2018;10(3):1-17.https://doi.org/10.3390/pharmaceutics10030104 25. Zhang L, Mao S. Application of quality by design in the current drug development. Asian J Pharm Sci. 2016;11(5):587-97.https://doi.org/10.1016/j.ajps.2016.07.006 26. Kim EJ, Kim JH, Kim MS, Jeong SH, Choi DH. Process analytical technology tools for monitoring pharmaceutical unit operations: a control strategy for continuous process verification. Pharmaceutics. 2021;13(9):1-45.https://doi.org/10.3390/pharmaceutics13060919 27. Lundin J, Jonsson R. Master of science in risk management and safety engineering.J Loss Prev Process Ind. 2002;15(2):111-7.https://doi.org/10.1016/S0950-4230(01)00060-2 28. Stersi MA, Rito PN. Gestão de riscos à qualidade: manual prático para uso da ferramenta FMEA em processos farmacêuticos. Rio de Janeiro: Fundação Oswaldo Cruz; 2019[acesso 13 set 2024]. Disponível em: https://www.arca.fiocruz.br/bitstream/handle/icict/37159/Manual%20FMEA%20processos%20farmaceuticos.pdf?sequence=2&isAllowed=y 29. Agência Nacional de Vigilância Sanitária – Anvisa. Guia de gerenciamento de riscos da qualidade: guia Nº 62. Brasília: Agência Nacional de Vigilância Sanitária; 2023[acesso 23 jan 2025]. Disponível em:http://antigo.anvisa.gov.br/documents/10181/6383200/Guia_62_GerenciamentoQualidade_Medicamentos.pdf/4bda3e21-c404-4e18-9783-0ff6da5f548e. 30. Santos WM. Gestão de risco aplicada ao controle de qualidade de medicamentos [dissertação]. Ouro Preto: Universidade Federal de Ouro Preto; 2023. 31. Kaleem AM, Koilpillai J, Narayanasamy D, Kaleem A. Mastering quality: uniting risk assessment with quality by design (QbD) principles for pharmaceutical excellence. Cureus. 2024;16(8):1-24.https://doi.org/10.7759/cureus.68215 32. Davis B, Lundsberg L, Cook G. PQLI control strategy model and concepts. J Pharm Innov. 2008;3(2):95-104.https://doi.org/10.1007/s12247-008-9035-1 33. Charoo NA, Shamsher AAA, Zidan AS, Rahman Z. Quality by design approach for formulation development: a case study of dispersible tablets. Int J Pharm. 2012;423(2):167-78.https://doi.org/10.1016/j.ijpharm.2011.12.024 34. Han JK, Shin BS, Choi DH. Comprehensive study of intermediate and critical quality attributes for process control of high-shear wet granulation using multivariate analysis and the quality by design approach. Pharmaceutics. 2019;11(6):1-25.https://doi.org/10.3390/pharmaceutics11060252 35. Claycamp HG, Kona R, Fahmy R, Hoag SW. Quality-by-design II: application of quantitative risk analysis to the formulation of ciprofloxacin tablets. AAPS PharmSciTech. 2016;17(2):233-44.https://doi.org/10.1208/s12249-015-0349-2 36. Costa CC, Penco GCN, Herrera MAL, Brandão MLL.Gerenciamento de riscos à qualidade: uma abordagem prática para a indústria farmacêutica. Rev Cient UBM. 2023;25(48):122-38.https://doi.org/10.52397/rcubm.v0i48.1425 37. Aleem H, Zhao Y, Lord S, McCarthy T, Sharratt P. Pharmaceutical process validation: an overview. Proc Inst Mech Eng Part E J Process Mech Eng. 2003;217(2):141-51.https://doi.org/10.1243/095440803766612801 38. Harpreet K, Gurpreet S, Nimrata S. Pharmaceutical process validation: a review. J Drug Deliv Ther. 2013;3(4):189-94.https://doi.org/10.22270/jddt.v3i4.547 39. Pazhayattil A, Ingram M, Duyan E, Zurita V. Put your continued process verification (CPV) data to work. Bioprocess Online. 22 maio 2020[acesso 19 ago 2024]. Disponível em: https://www.bioprocessonline.com/doc/put-your-continued-process-verification-cpv-data-towork-0001 40. Gamil AM. Validation as applied for pharmaceutical process. J Adv Pharm Educ Res. 2015;5(2):77-85. 41. Singh S, Hussain K, Ashok PK. Process validation approach for pharmaceutical formulation: an updated review. Int J Res Anal Rev. 2022;9(3):1-12.https://doi.org/10.13140/RG.2.2.10960.69122 42. Padickakunnel GS, Gupta NV. Modern FDA guidance and comparative overview of FDA and EMA on process validation. Int J Pharm Pharm Sci. 2014;6(4):14-17. 43. Govind R, Kant ARK, Nitin K. Basic concept of process validation in solid dosage form (tablet): a review. J Drug Deliv Ther. 2016;6(4):79-87.https://doi.org/10.22270/jddt.v6i4.1282 44. Sampathkumar K, Kerwin BA. Roadmap for drug product development and manufacturing of biologics. J Pharm Sci. 2024;113(2):314-31.https://doi.org/10.1016/j.xphs.2023.11.004 45. Pauli V, Kleinebuddeb P, Krumme M. From powder to tablets: investigation of residence time distributions in a continuous manufacturing process train as basis for continuous process verification. Eur J Pharm Biopharm. 2020;153:200-10.https://doi.org/10.1016/j.ejpb.2020.05.030 46. Das A, Kadwe P, Mishra JK, Moorkoth S. Quality risk management (QRM) in pharmaceutical industry: tools and methodology. Int J Pharm Qual Assur. 2014;5(3):13-21. 47. Boyer M, Gampfer J, Zamamiri A, Payne R. A roadmap for the implementation of continued process verification. PDA J Pharm Sci Technol. 2016;70(3):282-92.https://doi.org/10.5731/pdajpst.2015.006395 48. Paladini EP. Gestão da qualidade: teoria e prática. 3a ed. São Paulo: Atlas; 2012. 49. Bianchi SE, Souza KCB. Monitoramento do processo de compressão de ibuprofeno utilizando controle estatístico. Rev Cienc Farm. 2012;33(2):255-65. 50. Almaya A, Belder LD, Meyer R, Nagapudi K, Lin H-RH, Leavesley I et al. Control strategies for drug product continuous direct compression: state of control, product collection strategies, and startup/shutdown operations for the production of clinical trial materials and commercial products. J Pharm Sci. 2016;105(3):819-29.https://doi.org/10.1016/j.xphs.2016.12.014 51. Kharbach M, Cherrah Y, Heyden YV, Bouklouze A. Multivariate statistical process control in product quality review assessment:a case study. Ann Pharm Fr. 2017;75(5):319-25.https://doi.org/10.1016/j.pharma.2017.07.003 52. Monteiro DE, Fialho ICTS, Passos PM, Fuly PSC. Management of coping with the risks of COVID-19 in an onco-hematological outpatient clinic: an experience report. Rev Bras Enferm. 2021;74(Suppl.1):1-5.https://doi.org/10.1590/0034-7167-2020-1080 53. Machado JBF. A importância da ferramenta 5W2H nas organizações privadas para obter eficiência na tomada de decisões. Rev FT. 2023;27(123):1-17.https://doi.org/10.5281/zenodo.8010182