Sunday, 11 May 2014

The Importance of Quality Control in the Production of Parenteral Drugs

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.”

To read the article, go to APR.

Posted by Tim Sandle

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