Instrument Qualification - Validation, qualification and calibration are essential for proper analysis

Validation, qualification and calibration are essential for proper analysis

Exacting legislation requires producers of pharmaceuticals to conduct regular inspections of their raw materials, intermediates and end products. In order to ensure the required levels of accuracy, not only do analytical laboratories need highly qualified personnel but they also require up-to-date software and hardware. This is because laboratory teams must constantly validate, qualify and calibrate their methods and apparatus, including measuring instruments such as weighing scales and pipettes. Validation and qualification regulations are among the most strict to which analytical laboratories must adhere. In the USA and the EU, anyone applying for a licence to produce and sell drugs must satisfy these requirements. Under the regulations, inspections must be comprehensively documented as evidence of effective validation of methods and instruments.

Consistent quality assurance

Laboratory inspection procedure is determined by the Good Laboratory Practice (GLP) code. The first legal guidance on GLP was published in the US in 1978; following this, the OECD developed a set of principles to standardize laboratory work around the world. Today, these principles have been incorporated into the legal framework of many countries. GLP demands a thorough process of validation and qualification, which also helps improve the quality of inspection data. For instruments, the first step is Design Qualification (DQ), a process that shows the equipment is fit for purpose. The next steps are Installation Qualification (IQ) and Operation Qualification (OQ), which both aim to ensure that devices function correctly after installation. The final step, the Performance Qualification (PQ), takes place periodically during routine work, or sometimes before each individual measurement.

Merck’s unrivalled reference materials

For method validation, an inspection should cover e. g. accuracy, precision, linearity, repeatability and ruggedness, and should make use of traceable, certified reference materials (CRMs), such as Merck‘s Certipur^® reagents. These are secondary materials that can be traced back directly to standard reference materials (SRM) supplied by the US National Institute of Standards & Technology (NIST) or the Federal Physical-Technical Institute (PTB). Uniquely, Merck certifies many of its reference materials in its own accredited calibration laboratories. Both of the company‘s electrochemical and ICP laboratories are accredited in accordance with ISO 17025 – this means that Merck is the only manufacturer in the world that can guarantee the trueness of its reference materials to ISO 17025 standard, for a wide range of applications.

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