PDA TR28_无菌原料药（BPCs）的工艺模拟_Process Simulation_2006.pdfVIP

This document provides guidance relative to the validation of aseptic processing activities associated with the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts and principles developed in PDAs and PhRMAs prior publications on aseptic processing technology (1, 2, 3). This effort expands upon those documentstoprovide assistance for individualsand firmsproducing sterilebulk pharmaceutical chemicals. Our goal in this revision was to update the document to reflect 6 years of industry experience with it, as well as an acknowledgement of acceptance criteria limitations that were present in the first edition (4). We have also endeavored to address some of the issuesraised by FDA in their review of the earlier edition. PDA PhRMA 本文提供了无菌原料药生产加工有关的验证指导。它借鉴了 和 以前 1 2 3 出版的无菌加工技术 （， ， ）的概念和原则。这使得该文件可以为个人和企 业的无菌原料药生产提供帮助。我们在这次修订的目的是更新文件，以归纳6年 来的行业经验，以及验收标准的规定，这将在第1版 （4）中称述。我们还尽量列 举一些FDA对其早期版本的审查中提出的一些问题。 The preparation of sterile materials in the quantity and scale used in the manufacture of bulk pharmaceutical chemicals generally requires equipment and procedures quite different from those used in the manufacture of finished pharmaceuticals. The uniqueness of the production methods for sterile bulks precludes the direct extrapolation oftheprocess simulation approaches employed for aseptically produced sterileformulations. 原料药生产中，无菌原料在数量和规模上的准备，一般都需要与成品药的制造完 全不同的设备和程序。无菌原料生产方法的独特性，排除了用于无菌制剂的无菌 生产上的工艺模拟直接推断方法。 This technical report was disseminated in draft for public review and comment prior to publication. Many of the submitted comments have been included in the final document. We believe this approach accomplished the widest possible review of the document and ensures its suitability as a valuable guide to industry in the area of processsimulationtesting for sterilebulkpharmaceutical chemica