Dohmeier D M, Norwood D L, Reckzuegel G, Stults C L M, Nagao L M
International Pharmaceutical Aerosol Consortium on Regulation and Science, Washington, District of Columbia, USA.
Med Device Technol. 2009 Mar-Apr;20(2):32, 34, 36-8.
To maintain a high standard of quality in the materials and components used in the container systems of orally inhaled and nasal drug products, manufacturers need to collaborate closely with all those in the supply chain. Best practices in information sharing, particularly in relation to change control, are outlined here.
为确保口服吸入和鼻腔给药产品容器系统中所使用材料和组件的高质量标准,制造商需要与供应链中的所有相关方密切合作。本文概述了信息共享方面的最佳实践,尤其是与变更控制相关的实践。