1. Introduction

Analytical columns are essential components in analytical chemistry, influencing results in accordance with Pharmacopoeia and ISO 17025 standards. This document establishes the principles for their qualification.

2. Scope

The procedure applies to the qualification requirements and criteria for analytical columns used in laboratory settings.

3. Responsibility

Lab Chemist: Responsible for the receipt and qualification of analytical columns.

Lab Manager: Ensures the procedure is followed and provides necessary resources.

4. Procedure

4.1. General Handling Columns must be checked for physical damage upon receipt and verified against the purchase order.

4.2. Initial Qualification

Qualification must be performed upon receipt or before the first use.

Details such as column make, reference number, and dimensions must be documented in a qualification record.

Verification should be performed using manufacturer testing conditions or laboratory-defined test conditions.

Parameters like resolution, tailing factor, and theoretical plates are compared against the Certificate of Analysis (CoA).

Inventory is updated to include the column’s dimensions, serial number, and stationary phase.

4.3. Periodical Qualification

Efficiency checks should be performed periodically using the same method applied during initial qualification.

Initial results serve as a reference for subsequent qualifications, with acceptable variations defined by laboratory SOPs.

The frequency of qualification depends on usage, typically ranging from six months to one year.

4.4. In-Use Qualification

System suitability must be maintained during daily use to ensure performance.

Usage is tracked through a log that includes the number of injections, types of samples, and storage conditions.

5. Conclusion

Qualification results allow users to monitor column performance over time. A column is considered suitable for use when it meets pre-defined acceptance criteria or system suitability requirements.