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 ...

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

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

During 2017, the USP implemented two updates to <1058> (in August and December). These updates have a significant impact on AIQ, and as the only major pharmacopeia with a chapter dedicated to AIQ, changes to USP <1058> are of global significance.

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

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.

There are many ways of demonstrating that an instrument is qualified and under control, and these can include qualification, calibration, validation, and maintenance. In order to ensure “fitness for purpose”, an integrated approach, based upon a risk assessment, is recommended.

2022年9月18日 · All analytical instruments and systems for compendial use must be qualified to be "fit for intended use" using the guidance provided in the currently official general chapter Analytical Instrument Qualification 〈USP 1058〉.

Pharmaceutical companies must navigate a complex regulatory system, including 21 CFR Part 11 requirements, data integrity guidelines (ALCOA+), and USP <1058>, which outlines the entire process of analytical instrument qualification.

2023年1月7日 · In order to ensure “fitness for purpose”, an integrated approach, based upon a risk assessment, is recommended. Analytical Instrument Qualification (AIQ) is the collection of documented evidence that an instrument performs suitably for its intended purpose.