usp化学分析专家委员会认为本次更新是重组而不仅仅是修订。还建议将该章节重命名为<1058> 分析仪器和系统的确认。 文件内容. 新文件分为以下主要章节： 1. 介绍. 2. <1058> 与其他 usp 通则的相互关系. 3. 用于确认和验证的 生命周期流程. 4.

1058 Analytical Instrument Qualification INTRODUCTION A large variety of laboratory equipment, instruments, and computerized analytical systems, ranging from simple nitrogen evaporators to complex multiple-function technologies (see Instrument Categories ), are used in the pharmaceutical industry to acquire data to help ensure that products are ...

2014年5月4日 · There are four critical components involved in the generation of reliable and consistent data (quality data). Figure 1 shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. Analytical instrument qualification forms the base for generating quality data.

USP 〈1058〉 ANALYTICAL INSTRUMENT QUALIFICATION Official as of 1-Aug-2017 INTRODUCTION A large variety of analytical instruments, ranging from a simple apparatus to complex computerized systems, is used in the pharmaceutical industry to acquire data that will help ensure that products meet their specifications. Many of these instruments combine

〈1058〉 Analytical Instrument Qualification INTRODUCTION A large variety of analytical instruments, ranging from a simple apparatus to complex computerized systems, is used in the pharmaceutical industry to acquire data that will help ensure …

General chapter 〈1058〉 is unique in the regulatory sector. It is widely regarded and used globally by regulators, suppliers, and industry. It provides a framework for establishing “fitness for intended use” of apparatus, analytical instruments, and systems.

2020年10月29日 · Many USP–NF analytical instrument chapters ha ve been revised to include concepts that align with 〈 1058 〉 , yet they are inconsistent in their use of CRMs, in their acceptance limits for accuracy and precision, and in their position on the use of user-prepared reference materials for

The US Pharmacopeia (USP) general chapter <1058> on Analytical Instrument qualification (AIQ) was first implemented in 2008 and remained unchanged for nine years. During 2017, the USP

gen content of the USP Reference Standard or reference material. 〈1058〉 ANALYTICAL INSTRUMENT QUALIFICATION INTRODUCTION A large variety of laboratory equipment, instruments, and Figure 1. Components of data quality. computerized analytical systems, ranging from simple nitro-gen evaporators to complex multiple-function technologies

AIQ 有着重大影响，USP <1058> 作为唯一一部具有专门针对 AIQ 的章节的主流药 典，其变更具有全球性意义。 为了帮助法规监管实验室完全符合 2017 <1058> 的要求，安捷伦联合法规认证顾问 Bob McDowall 共同出版了四本白皮书，Bob McDowall 曾密切参与了 <1058> 的开 发。