Greenberg L
Bull Pan Am Health Organ. 1975;9(1):27-31.
The manufacture of safe effective biological products in sufficient quantities to protect the entire population presents many problems in Latin America. The best way of ensuring such production would be to establish thorough control testing mechanisms. Ideally, no regulatory program should be considered complete without three tiers of controls: "in-process" production controls; "internal" controls by the manufacturer that monitor the production section; and "national" controls by the government that monitor the manufacturer. Although the standards maintained by some biologicals manufacturing centers in Latin America are very high, no country has yet established a full-fledged three-level control system of this kind. However, two countries have decided to employ such a system and are now close to achieving that goal. Perhaps the most essential facility in any national control program is the National Biologics Control Laboratory. This laboratory must be effectively organized, properly staffed, and backed by strong implementing legislation enabling it to perform its assigned tasks. In the past, lack of such a facility has created serious problems for biologicals manufacturing efforts in Latin America. Aware of this, a number of countries are now in the process of setting up and developing effective national laboratories of this kind
在拉丁美洲，生产足够数量的安全有效的生物制品以保护全体民众面临诸多问题。确保此类生产的最佳方式是建立全面的控制检测机制。理想情况下，没有三层控制，任何监管计划都不应被视为完整：“生产过程中”的生产控制；制造商的“内部”控制，用于监督生产部门；以及政府的“国家”控制，用于监督制造商。尽管拉丁美洲一些生物制品生产中心维持的标准非常高，但尚无国家建立起如此完备的三级控制系统。不过，有两个国家已决定采用这样的系统，目前正接近实现这一目标。或许任何国家控制计划中最关键的设施就是国家生物制品控制实验室。该实验室必须组织高效、人员配备得当，并得到强有力的实施立法支持，使其能够履行指定任务。过去，缺乏这样的设施给拉丁美洲的生物制品生产工作带来了严重问题。鉴于此，一些国家目前正在着手建立和发展此类有效的国家实验室。
