Contamination in drug products is a common problem in the pharmaceutical industry that can have major impacts on pharmaceutical companies, from both financial and safety aspects. Inhalable drug products are unique with regards to the affects of contamination, due to enduse design. Inhalation of foreign particles can lead to particle settlement in the alveolus, which (depending on the size and distribution of the particles) can lead to such contraindications as allergic reactions, pain, inf lammation, adverse immune responses, aggravated asthma, chronic bronchitis and acute respiratory affects.
The US Food and Drug Administration (FDA) has taken action against companies specifically for violations involving inadequate investigations of contamination failures within products. Warning letters include verbiage such as “…the black particles were not identified and source was not determined. In addition, there was no attempt to determine if the black particles originated from the manufacturing process, or if additional lots were affected…” and “Reddish-brown particulate matter has been a recurring problem…The cause of the particulate matter problem has not been determined.” These statements indicate that merely the detection of foreign particulate contamination is not sufficient in itself, but that the identification and source determination of the contaminants is necessary.
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