Increasing attention is paid every year to the quality of pharmaceutical products. European and North American regulations, in particular, continue to raise quality levels required for drug commercialisation.
The rise in the production demands further attention be paid to two potential issues, both harmful for patients:
All the particles that do not belong to the drug itself or to the package, but that are rather unexpected
All the particles that arise from sources related to the pharma production itself or to the package, but that should not be in the final product
All the particles that are expected to be present but in a lower quantity or concentration. This compels pharmaceutical companies to look for new technologies capable of responding to these requirements
Effective in detecting non-transparent foreign bodies, if containers and drugs are transparent. Possibility to discover new foreign bodies or container defects thanks to human expertise. Controls on the entire production line.
Ineffective in case of non-transparent drugs or containers. Analysis of small samples. Quality control dependent on potential human errors. Impossibility to detect and classify new defect types.
Valuable information about the chemical properties of the samples tested.
Complexity of the instruments involved. Very slow inspection process, therefore rather suitable for laboratory environments. Need for highly skilled technical staff.