Abstract
Good manufacturing practices include the concept of equipment qualification which aims to demonstrate in a documented way that equipment operates correctly for its intended use and that it is properly maintained and calibrated.
Equipment qualification is the base to generate quality data and is formed by four phases: Dq, IQ, OQ and PQ. This article presents how to carry out OQ for a liquid chromatograph.
A proposed OQ for a liquid chromatograph is based on a variety of tests that evaluate equipment from a modular point of view. There have also been discussed and set appropriate acceptance criteria whose selection has been based on a search and examination of the criteria used by manufacturers and an exhaustive study of equipment historical results.
Equipment qualification is the base to generate quality data and is formed by four phases: Dq, IQ, OQ and PQ. This article presents how to carry out OQ for a liquid chromatograph.
A proposed OQ for a liquid chromatograph is based on a variety of tests that evaluate equipment from a modular point of view. There have also been discussed and set appropriate acceptance criteria whose selection has been based on a search and examination of the criteria used by manufacturers and an exhaustive study of equipment historical results.
| Translated title of the contribution | ¿Estamos de acuerdo con la cualificación operacional que proporcionan los fabricantes de cromatógrafos de líquidos? |
|---|---|
| Original language | English |
| Pages (from-to) | 6-12 |
| Number of pages | 7 |
| Journal | Afinidad |
| Volume | 70 |
| Issue number | 561 |
| Publication status | Published - 2013 |
Keywords
- Analytical instrument qualification
- Equipment qualification
- Liquid chromatography
- Operational qualification
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