who验证指南版本.docxVIP

INTRODUCTION 简介 1.1 Validation is an essential part of good practices including good manufacturing practices (GMP) (4) and good clinical practices (GCP).It is therefore an element of the pharmaceutical quality system. Validation, as a concept, incorporates qualification and should be applied over the life cycle of, e.g. the applicable product, process, system,equipment or utility. 验证是包括 GMP 和 GCP在内的良好规范的必要部分。 因此是制药质量体系的组成部分。 验证这个概念包括确认并且应该在产品、工艺、系统、设备或设施的整个生命周期中被 使用。 1.2 These guidelines cover the general principles of validation and qualification. In addition to the main part, appendices on