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配制与重新包装——完整记录的必要性。

Compounding and repackaging--a need for complete records.

作者信息

Proksch R A

出版信息

Hosp Pharm. 1980 Jul;15(7):344-5, 349-50, 352-5.

Abstract

The necessity for adequate record systems is discussed in relation to repackaging and compounding activities. Sample forms are presented. Basic requirements associated with governmental and professional regulations and guidelines are detailed. Specific governmental regulatory agencies do not now directly monitor hospital pharmacy in terms of Good Manufacturing Practices; however, professional and legal criteria should be appraised to account for what may be construed as the "state of the art." An example of one type of record system is presented for review.

摘要

本文讨论了与重新包装和配制活动相关的完善记录系统的必要性。文中展示了样本表格。详细说明了与政府和专业法规及指南相关的基本要求。目前,特定的政府监管机构并未依据药品生产质量管理规范直接监管医院药房;然而,应当评估专业和法律标准,以考量可能被视为“先进技术水平”的内容。文中给出了一种记录系统的示例以供参考。

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