Last year topical antiseptics came under US Food and Drug Administration (FDA) scrutiny after Triad’s products were linked to adverse events and subject to microbial contamination-related recalls and seizures.
“Microbial contamination may be caused by substandard manufacturing practices and the agency is concerned about safety risks, such as from infection, associated with this contamination”, the FDA wrote.
In response the FDA has updated its GMP (good manufacturing practice) question and answer page with information about preventing microbial contamination of topical antiseptic drug products.
Understanding risk is part of the anti-contamination strategy. “It is imperative that manufacturers perform a manufacturing risk assessment to understand manufacturing failure modes and implement prevention measures”, the FDA wrote.
Manufacturers should know what microbes their products are vulnerable to contamination with and what extra controls and tests this necessitates. Potential risks in the production process should also be considered.
High humidity, using materials from natural sources and storing products in open bins all increase the risk of contamination, the FDA said. Manufacturers should also be wary of water quality.
“Contaminated purified water has been the root cause of multiple recalls of antiseptics, including instances of antiseptics contaminated with Burkholderia cepacia, an opportunistic pathogen”, the FDA wrote.
The FDA also highlights specific GMP regulations of relevance to manufacturers of topical antiseptics. Many focus on aspects of the production process, such as validation studies, but the FDA also notes the role of management.
“CGMPs require that the management of a manufacturing facility maintains a well-functioning quality system, which includes an effective quality unit vested with the responsibilities and authorities required under cGMP”, the FDA wrote.