Millenium Institute on Immunology and Immunotherapy, Departamento de Genética Molecular y Microbiología, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile.
Deeks Pharmaceutical Consulting Services, Rockville, MD, United States.
Front Public Health. 2022 Nov 3;10:1021905. doi: 10.3389/fpubh.2022.1021905. eCollection 2022.
The manufacture of pharmaceutical products made under good manufacturing practices (GMP) must comply with the guidelines of national regulatory bodies based on international or regional compendia. The existence of this type of regulation allows pharmaceutical laboratories to count on the standardization of high-quality production processes, obtaining a safe product for human use, with a positive impact on public health. In addition, the COVID-19 pandemic highlights the importance of having more and better-distributed manufacturing plants, emphasizing regions such as Latin America. This review shows the most important GMP standards in the world and, in particular, their relevance in the production of vaccines and antibodies.
药品的生产必须符合基于国际或地区典集的国家监管机构的指导原则，这些药品是按照良好生产规范（GMP）生产的。这种规定的存在使制药实验室能够依靠高质量生产过程的标准化，获得可安全用于人类的产品，从而对公共健康产生积极影响。此外，COVID-19 大流行凸显了拥有更多和分布更广的生产工厂的重要性，拉丁美洲等地区受到了特别关注。这篇综述展示了世界上最重要的 GMP 标准，特别是它们在疫苗和抗体生产中的相关性。
