Laboratory Analysis

Laboratory Analysis

Not all countries have ready access to quality assurance laboratories to test suspected SF medical products. In many regions Laboratories are frequently under resourced in terms of equipment and trained personnel, and are already under pressure with large workloads. Laboratory testing is also expensive and time consuming, which means that SF products may not always undergo the degree of analysis required.

Many SF medical products can be identified through visual examination of the product and its packaging, however some falsified medicines are almost visually identical to the genuine product and only quality control analysis will determine that they are falsified.

It is recognised that a number of field screening technologies are in use and prove successful in identifying suspected SF products. Whilst not a replacement for full quality testing in a laboratory they are effective in conducting a triage of suspected products allowing the selection of these products which should undergo deeper analysis.

In most cases of suspected falsified medicines the suspected product will also be sent to the genuine manufacturer (where known) for their own analysis.

A three stage process has been adopted in a number of countries.

Failure during field screening should normally lead to submission to a quality assurance laboratory for validation. Occasionally more complex analysis may be required, in which case suspected products may be submitted to a forensic laboratory.

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