Garnick R L
Genentech, Inc., South San Francisco, CA, USA.
Dev Biol Stand. 1997;91:31-6.
The emergence of new analytical technology and the production of pharmaceuticals for a global market in a cost-effective manner necessitate the establishment of worldwide specifications that are appropriate for the product and the manufacturing process. This requires a thorough knowledge of the protein and control of the systems that produce it as well as an understanding of the accuracy and precision of the assays used for testing. Harmonization of specifications among the worldwide regulatory authorities is critical for the future development of new pharmaceuticals. A continuing dialogue between industry and regulators to achieve this goal needs to be encouraged and supported.
新分析技术的出现以及以具有成本效益的方式为全球市场生产药品，使得有必要制定适用于产品和制造工艺的全球规范。这需要对蛋白质有透彻的了解，对生产蛋白质的系统进行控制，以及理解用于测试的分析方法的准确性和精密度。全球监管机构之间规范的协调统一对于新药品的未来发展至关重要。需要鼓励和支持行业与监管机构之间为实现这一目标而持续开展对话。
