Cara
N. Wilder and Elizabeth Kerrigan have written an interesting article for the
American Pharmaceutical Review on QC testing during pharmaceutical
manufacturing. Here is an extract:
“Microbial
contamination of parenteral products is one of the most serious issues
currently facing the pharmaceutical industry. Injectable drugs, which are
administered directly into the circulatory system, bypass a number of innate
human immune defenses associated with the gastrointestinal system. Therefore,
to ensure the sterility of each of these products prior to patient
administration, pharmaceutical companies must adhere to strict government
regulations regarding quality control. Maintaining and following a robust
quality control program is integral to quality standards and meeting regulatory
requirements.
Adding
to these pressing concerns are compounding pharmacies that function
inappropriately as drug manufacturing companies, but are not legally required
to adhere to federal drug manufacturing regulations. Rather, they function
under more lenient state policies that govern their operation, but do not
enforce quality control analysis. This lack of regulation and oversight has led
to several significant microbial outbreaks, which have resulted in multiple
deaths from use of contaminated parenteral steroids, cardioplegia solutions,
and intravenous drugs. These events highlight the importance of effective
pharmaceutical sterility procedures as well as the need for updated regulatory
control policies governing the operation of compounding pharmacies. In this
article, we will discuss current practices and issues associated with
pharmaceutical quality control analysis, how these can affect patient health
and safety, and what could be done to remedy the issue.”
Posted by Tim Sandle
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Pharmaceutical Microbiology Resources