Identification and Sourcing of Particulate Matter in Pharmaceutical Products

Palenik, C.S. and Palenik, S.J. (2013) Applications of Forensic Microanalytical Methods to the Identification and Sourcing of Particulate Matter in Pharmaceutical Products. Microscopy and Microanalysis (Indianapolis, IN) .

Presented by Jason Beckert on: 8/1/2013

The identification and source determination of contaminants (or alleged contaminants) in pharmaceutical products has much in common with the forensic analysis of trace evidence that is encountered in the course of criminal investigations. Similar laboratory techniques are employed by both fields to detect, isolate, analyze and identify microscopic quantities of unknown substances or single small particles of interest. They differ primarily in their end uses: In the pharmaceutical industry, the primary goal is to locate the source of the identified foreign matter so that it can be eliminated from future lots of product, while in a criminal proceeding it is to provide clues to advance an investigation or to be presented as evidence at trial. As sensational reports of contaminated food and drugs have made the headlines in recent years, there is increased scrutiny of even innocuous foreign matter by the legal profession and litigious consumers. It has become of some interest, therefore, to perform laboratory analyses of foreign matter discovered in pharmaceutical products according to guidelines similar to those followed in the forensic science laboratory to prevent accusations that “proper procedures” were not followed, either by administrative agencies or by lawyers or courts. As a forensic trace evidence analysis laboratory that also conducts analysis of foreign matter for pharmaceutical companies, not only in North America but throughout much of the world, we have first-hand experience in the application to forensic methods of analysis to such problems.

In this presentation we will demonstrate, by means of examples from actual projects from our files, how alleged foreign matter in pharmaceuticals (both parenteral solutions, solid dosage forms, and laminates) may be located, isolated, analyzed and identified. It will also stress how seemingly minor procedures such as proper documentation, packaging, chain-of-custody, sample preservation, and ultimately the production of a self-contained narrative report are significant to the process and how they can be simultaneously implemented into the analysis process. The report as the final work product should contain sufficient supporting analytical data and observations documented by means of macro-photographs, spectra, chromatograms, photomicrographs and any other data that was obtained and relied upon to form the conclusions. Since such conclusion are, of necessity, at least partially subjective, the report must clearly state the reasoning used to arrive at it and how the data supports it. The clear separation of the facts (data and observations) and the interpretation of them that led to the conclusion(s) of identity, probable source, etc., must be clearly stated to minimize the possibility of misinterpretation.

Normally, detection (location) of contaminants presents little problems, since they are often obvious upon an initial inspection. For example, a white tablet shows colored spots, abnormally high particle counts are detected by an automated particle size instrument, or particles are seen floating in a drug solution in a vial. Occasionally, they are not so obvious and microscopical inspection, often assisted by atypical lighting geometries or alternate light sources (i.e., different wavelengths of light) is required to find them.

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