Pharmaceutical Technology Brasil Ed. 2-24

Pharmaceutical Technology 32 Edição Brasileira - Vol. 28 / Nº2 Boas Práticas de Distribuição reali- zado em 23 de março de 2022, a USP promoveu a elaboração de uma mo- nografia para estabelecer os limites de temperatura de excursão aplicáveis à zona climática IVb. A Tabela 4 reproduz os critérios a serem adotados pela USP a partir de sua vigência. Este estudo de mapeamento de rotas de transporte rodoviário de medicamentos no Brasil foi realizado pela Ita Fria Indústria e Comércio Ltda., sob os auspícios da Associação Brasileira do Atacado Farmacêutico (Abafarma) e da Associação Brasileira de Distribuição e Logística de Produtos Farmacêuticos (Abradilan). A redação e análise deste artigo foi feito pelos autores de forma independente. Referências bibliográficas • ANVISA - RDC Nº 318, de 6 de novembro 2019. DOU nº 216, de 7 de novembro de 2019, Brasília-DF. • ANVISA. RDC Nº 430, de 8 de outubro de 2020. Di- retrizes Gerais de Boas Práticas de Armazenagem e Transporte de Medicamentos. DOU nº 195, de 9 de outubro de 2020, Brasília-DF. • ANVISA. RDC Nº 653, de 24 de março de 2022. DOU nº 61 de 30 de março de 2022, Brasília-DF. • BRAGA, G. K.; TAKARA, L. S.; HUNT, D. G. USPWorkshop on Good Distribution, Storage and Transport Practi- ces of Drug Products. USP Technical Report. Apud. https://qualitymatters.usp.org/sites/default/files/ user-uploaded-files/Technical-Report-Workshop- on-Good-Distribution-Practices-March-2022.pdf. Acessado em 30/01/024 às 22:41. • BRAGA, G.K., TAKARA, L.S., ANDERSONS, C.J., SEEVERS, R.H., NIELSENS, S. K., HUNT, D.G. The Use of Mean Kinetic Temperature and the Need of Allowable Excur- sion Limits for Climatic Zone IVb. Apud. https://www. uspnf.com/sites/default/files/usp_pdf/EN/USPNF/ usp-nf-notices/gc-1079-stimuli-prepost-20230127. pdf. Acessado em 30/01/2024 às 22:33. • FUTSHCHER, N., SCHUMACHER, P. Climatic zones of the Earth. Pharm. Ind. 34: 479-483, 1972. • GRIMM, W. Storage conditions for stability testing in the EC, Japan, and USA; the most importat market for drug products. Drug Dev. Ind. Pharm., V. 19, nº 20, p. 2795-2830, 1993. • GRIMM, W. Storage conditions for stability testing. Long term tests and stress test. Drugs Made in Ger- many. Vol. 28/29, p. 1-12, 1985/1986. • HAYNES,J.D.Worldwidevirtualtemperaturesforproduct stability testing. J Pharm. Sci., 60(6), 927–929, 1971. • ICH (International Council of Harmonization). Guidan- ce for Industry. Q1A(R2) Stability Testing of NewDrug Substances and Products. FDA, 2003, 22p. • SEEVERS, R.H., HOFER, J., HARBER, P., ULRICH, D.A., BISHARA, R. The Use of Mean Kinetic Temperature (MKT) in the Handling, Storage, and Distribution of Temperature Sensitive Pharmaceuticals. Pharmaceu- tical Outsourcing. May/June, P.12-17, 2009 • UNITED states pharmacopoeia (USP). <1079.2> MEAN KINETIC TEMPERATURE IN THE EVALUATION OF TEMPERATURE EXCURSIONS DURING STORAGE AND TRANSPORTATION OF DRUG PRODUCTS. Apud. https://www.uspnf.com/sites/default/files/usp_pdf/ EN/USPNF/usp-nf-notices/gc-1079-chapter-pre- post-20230127.pdf. Acessado em 13/02/2024 às 23h04. • UNITED states pharmacopoeia (USP). General Chapter <1079.2>: Mean Kinetic Temperature in the Evalua- tion of Temperature Excursions during Storage and Transportation of Drug Products. Apud. https://online. uspnf.com/uspnf/document/1_GUID-C65501B2- 4215-49ED-8563-BBCE2760D93E_2_en-US. Printed on: Thu Jun 24 2021, 11:39:31 AM • UNITED states pharmacopoeia (USP). General Chap- ter <659>: Packaging and storage requirements https://online.uspnf.com/uspnf/document/GUID- 48C0134E-8117-4B3B-8DC4-EA70C93EEE8F_3_en- US?highlight=659. Printed on: Fri Jan 17 2020, 12:08:20 pm • VALS, N.R.M., MORETTO, S., MORETTO, L.D. Tempera- tura cinética média do Brasil. Estudo preliminar e po- tenciais aplicações. Pharm. Technol. Edição Brasileira. V. 26, nº 3, p. 52-56, 2022. • WORLD Health Organization (WHO). WHO Expert Committee on Specifications for Pharmaceutical Preparations, 22th Report, Draft Requeriments for Good Manufacturing Practices in the Manufacture and Quality Control of Drugs and Pharmaceutical Specialties. TRS Nº 418, Geneve, 1969. • WORLD Health Organization (WHO). Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. TRS, No. 953, Annex 2, 2009. • WORLD Health Organization (WHO). WHO Expert Committee on Specifications for Pharmaceutical Preparations,Thirty-fourthReportTRSNº863,Geneva, 1996, 98p.