Agilent Operational Qualification Performance Verification of UV-visible Spectrophotometers Technical Note

About this manual

This document addresses the increasing importance of quality requirements, such as ISO 9000, GLP, GMP, and pharmacopeia regulations, for the pharmaceutical industry. It defines Operational Qualification (OQ) and Performance Verification (PV) as a series of tests designed to prove that an instrument is working within a set of required specifications. The text highlights the challenges in performing these verifications due to regulatory constraints and the lack of easy-to-use standards.

What's inside

• Introduction
• Regulatory requirements
• Good laboratory practice and good manufacturing practice
• United States Pharmacopeia
• European Pharmacopoeia
• Recommended OQ/PV test parameters and standards
• Regulatory test requirements

Frequently asked questions

What is the definition of Operational Qualification and Performance Verification?

Both terms are used to mean a series of tests designed to prove that an instrument is working within a set of required specifications.

What is the permitted tolerance for wavelength control in the UV range according to the European Pharmacopoeia?

The permitted tolerance is + 1 nm for the UV range.

Which standard solution is recommended for checking the absorbance scale according to the European Pharmacopoeia?

A solution of potassium dichromate R is recommended for checking the absorbance.