High performance liquid chromatography – HPLC – is very often the method of choice for analyzing pharmaceutical compounds starting with R&D and continuing into manufacturing. Among other things it is used to
- Check candidate drugs for purity
- Monitor changes in pharmaceutical intermediates during chemical synthesis scale up
- Test the stability and dissolution of formulations in development and
- Support quality control in final drug products
Identifying an analyte by HPLC is based on accurate and reproducible column retention time as it passes through an HPLC system. Reproducible retention time is critical and depends on uniform, reproducible HPLC pump flow rates. A leak developing or other malfunction in the HPLC system will result in analysis errors. Obviously, then, continuous testing is necessary to insure that the HPLC system is properly calibrated. This is called operational qualification. OQ starts before the HPLC system is put into use and as part of ongoing system … Read the rest
With continuous press reports on product recalls ranging from automobiles to pharmaceuticals to baby cribs, quality management (QM) takes on every greater importance for company management, its personnel, customers and shareholders regardless of size, product or service. The cost of product recalls in terms of lost revenues, reputation and lawsuits – let alone loss of life or health – presents a strong case for strong quality management systems in any company.
QM systems can be broadly divided into quality practices and quality standards. Learn which of these apply to your organization. Compliance procedures should be carefully spelled out in your company’s operation manual. Record-keeping is crucial. These must be maintained in a safe location and accessible by qualified third parties.
Some Examples of QM Practices
Here are some examples of QM practices. Detailed information on these and others is available on the Internet.… Read the rest
Accurate HPLC flow rate records not only indicate GMP but are crucial when the FDA comes to call. Digital liquid flow meters such as the FlowCal 5000 support FDA compliance for IQ, QQ and PQ validations in calibrating HPLC pump flow rates. Connecting these meters to a PC with an RS-232 interface transfers flow meter readings into Excel via the Windows HyperTerminal program. It is a three-step process whereby data are collected and displayed using HyperTerminl.exe, copied on a clipboard and pasted into Excel for analysis.
Before starting on this project be sure the flow meter is off, otherwise you risk damage to the RS-232 and/or the PC or printer. Then follow these steps:… Read the rest