High-Performance Liquid Chromatography (HPLC) is arguably the most crucial equipment in pharmaceutical quality control laboratories. The most fundamental and sensitive analyses are performed using HPLC systems, and without quality confirmation of the produced product through these analyses, the drug manufacturing process would be disrupted. Therefore, ensuring the performance and qualification of each module of this equipment is highly important and is a requirement of pharmaceutical and laboratory standards.

• Initial review of existing documentation, needs assessment, and provision of free consultation

• Provision of protocol and completion of Installation Qualification (IQ) documentation

• Provision of protocol, execution of tests, and delivery of Operational Qualification (OQ) documentation

• Provision of protocol, execution of tests, and delivery of Performance Qualification (PQ) documentation

In the Operational Qualification (OQ) process for these systems, a modular (component-by-component) approach is taken. This means each module of the system (pump, injector, column oven, and detector) is individually examined across its operational range. In the Performance Qualification (PQ), a holistic approach is used, and tests that demonstrate the overall system performance are conducted on the entire instrument.

If required, this company provides pre-purchase consulting services and, upon request, the documentation related to Design Qualification (DQ).

To learn more about the details of the tests, please complete and submit the relevant equipment qualification form.