Posts Tagged ‘digital flow meter’
How to Check Pump System Accuracy for HPLC Analysis
Pump system accuracy is crucial for equipment used to conduct high performance liquid chromatography (HPLC) analysis in the pharmaceutical and other industries subject to regulatory oversight by the FDA and similar authorities. Among functions performed by HPLC are included checks for purity, monitoring changes in pharmaceutical intermediates during chemical synthesis scale-up, stability and dissolution tests, and performing ongoing quality control procedures.
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A Brief on HPLC Analysis
Identifying an analyte by HPLC is based on accurate and reproducible column retention time as the analyte is pumped through an HPLC system. Reproducible retention time is critical and depends on accurate, uniform, reproducible HPLC pump flow rates.
Note that it is important to distinguish between accuracy and precision. These two terms may seem the same but they are not necessarily so. For example, an HPLC system (or for that matter many other systems such as analytical scales) may … Read the rest
Navigating Quality Management Systems
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
