Revista Farmespaña Industrial Mayo - Junio 2024

escenario posible, incluidas las intervencio- nes representativas del proceso. Igualmente, importantes son los programas sólidos y efi- caces de limpieza y desinfección de las salas blancas, de limpieza y mantenimiento de los equipos y de validación de los procesos de esterilización. Para garantizar el cumplimien- to de la normativa en materia de buenas prácticas de fabricación, así como el éxito de un programa APS, será necesario contar con operadores y personal de apoyo com- petentes, bien formados en técnicas y com- portamiento asépticos, con conocimientos adecuados de microbiología y capacidad de investigación de desviaciones y fallos ◉ Bibliografía 1. Chai, R. y Barber, D. “Validation of Aseptic Processes”, Pharmaceuti- cal Engineering, Volumen 42 No. 2, marzo-abril 2022. 2. European Commission. “EudraLex, Volume 4: EU Guidelines for GMPs for Medicinal Products for Human and Veterinary Use. Part 4: EU Guidelines for Good Manufacturing Practice (GMP) Specific to Advan- ced Therapy Medicinal Products.” noviembre 2017. https://ec.europa. eu/health/sites/health/files/ files/eudralex/vol-4/2017_11_22_ guidelines_gmp_for_atmps.pdf 3. European Commission. “Eudra- Lex, Volume 4: EU Guidelines for GMPs for Medicinal Products for Human and Veterinary Use. Annex 1: Manufacture of Sterile Medicinal Products.” Publicado 2008. https:// ec.europa.eu/health/sites/de- fault/files/files/gmp/2017_12_pc_ annex1_consultation_document.pdf 4. European Commission. “EudraLex, Volume 4: EU Guidelines for Good Manufacturing Practices for Medi- cinal Products for Human and Ve- terinary Use. Annex 13: Investigatio- nal Medicinal Products.” Publicado 2017. https://ec.europa.eu/health/ sites/health/files/files/eudralex/ vol-4/2009_06_annex13.pdf 5. US 21 Code of Federal Regulations Part 210 Current GMP in Manufactu- ring, Processing, Packing or Holding of Drugs; General. Actualizado el 13 de septiembre de 2021. https:// www.ecfr.gov/current/title-21/ chapter-I/subchapter-C/part-210 6. US 21 Code of Federal Regulations Part 211 Current GMP for Finished Drug Products. Actualizado el 14 de septiembre de 2021. https://www. ecfr.gov/current/title-21/chap- ter-I/subchapter-C/part-211 7. US Food and Drug Administration. “Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Ma- nufacturing Practice.” septiembre 2004. https://www.fda.gov/me- dia/71026/download 8. WHO Expert Committee on Specifications for Pharmaceuti- cal Preparations. Annex 2 WHO Good manufacturing practices for pharmaceutical industries; Main Principles. Publicado 2014. 9. WHO Expert Committee on Biologi- cal Standardization. Annex 4 General requirements for sterility of biologi- cal substances. Publicado 1973. 10. Pharmaceutical Inspection Con- vention/Pharmaceutical Inspection Co-Operation Scheme. “Recom- mendation on the Validation of Aseptic Processes.” Publicado enero 2011. https://picscheme.org/ docview/3446 11. PDA Technical Report #22, “Pro- cess Simulation for Aseptically Filled Products.” Revisado 2011. 12. ISO Standard 13408-1. “Aseptic Pro- cessing of Health Care Products – Part 1: General Requirements.” Publicado junio 2008. https://www. iso.org/standard/37842.html 13. ISO Standard 14664-1:2015. “Clean- rooms and Associated Controlled Environments — Part 1: Classifica- tion of Air Cleanliness by Particle Concentration.” Publicado 2015. https://www.iso.org/obp/ui/#i - so:std:iso:14644:-1:ed-2:v1:en 14. ISO Standard 14664-1:2015. “Clean- rooms and Associated Controlled Environments — Part 2: Monitoring to Provide Evidence of Clean- room Performance Related to Air Cleanliness by Particle Concen- tration.” Publicado 2015. https:// www.iso.org/obp/ui/#iso :std:i- so:14644:-2:ed-2:v1:en 15. Hamilton, D., Tharp, T., McGarvey, O., Frei, M., Dekner, M., Mehta, S.B., Chen, X., Zinfollino, N., Schneid, S., Briggs, J., Schreyer, M. y Hill, D. “A Better Approach to Aseptic Process Simulation For Lyophilized Pro- ducts” Outsourced Pharma Publi- cado el 9 de mayo de 2021. https:// www.outsourcedpharma.com/ doc/a-better-approach-to-asep- tic-process-simulation-for-lyophili- zed-products-0001 CONTROL DE CALIDAD 39 FARMESPAÑA INDUSTRIAL · MAY/JUN 24