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    AIQ 소개와 Validation, versus Qualification 의미 이해
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Analytical Instrument Qualification 개요
밸리데이션의 대상과 목적에 따라 FDA, ICH, EMA, OECD, USP 등 다양한 국제기관에서 내놓은 규정을 이해하고 참고해야 한다. 분석장비 또는 실험실에서 사용하는 다양한 실험기구의 밸리데이션 기초라고 할 수 있는 적격성평가(Qualification) 와 검교정(Calibration)은 USP에서 권하는 1058 규정이 가장 널리 받아들여지고 있어 그 내용을 기초로 분석장비의 밸리데이션을 소개한다.
 
USP 1058 AIQ(분석장비적격성평가) 의 개요
 
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 suitable for their intended use. An analyst's objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures, calibrate their instruments, and perform additional instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify their instruments.
Unlike method validation and system suitability activities, analytical instrument qualification (AIQ) currently has no specific guidance or procedures. Competing opinions exist regarding instrument qualification and validation procedures and the roles and responsibilities of those who perform them. Consequently, various approaches have been used for instrument qualification, approaches that require varying amounts of resources and generate widely differing amounts of documentation. This chapter provides a scientific approach to AIQ and considers AIQ as one of the major components required for generating reliable and consistent data. Note that the amount of rigor applied to the qualification process will depend on the complexity and intended use of the instrumentation. This approach emphasizes AIQ's place in the overall process of obtaining reliable data from analytical instruments.
 
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입문자들을 위한 용어 정의를 짚고 넘어가기 이다. 쉽게 이해하기는 Validation 은 전체(큰 범위)이고 Qualification 은 그 안에 구성되는 구성요소로 생각하는 방향이다.
해석은 오히려 정확한 의미를 훼손하는 우려가 있어 원문을 그대로 가져왔다.
 
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The terms validation and qualification are frequently mixed up and there is also some overlap. Equipment qualification means checking an instrument for compliance with previously defined functional and performance specifications. For Operational Qualification, generic standards and analytical conditions are used rather than real sample conditions. Validation relates more to the entire but sample specific process including sample preparation, analysis, and data evaluation. For software, validation includes the whole process from design to retirement of the product. It should include processes that address on-going support and (change) control of the system. Qualification here is more concerned with testing the compliance of individual phases with specifications.

-- From FDA's Glossary --