The Pharmaceutical Supply Chain: How Repackers Are Affecting Public Health
The pharmaceutical supply chain process involves many safeguards to protect the public. While other manufacturers can distribute products directly to consumers, our market pathway is through a pharmacy or wholesale distributor. Before this step happens, registered repackers may be manipulating your API for packaging. Careful attention must be paid to contracting this work, as recently problems regarding cross-contamination and a lack of biotech quality assurance training has the FDA on alert.
The FDA began sending out warnings to popular repackers of active pharmaceutical ingredients because of their failure to follow CGMP and various CMC training regulations. For example, it’s been noted that prominent packers fail to include pieces of vital information on their certificate of analysis. This puts users at harm because the omitted quality and sourcing information could affect them in some way.
Another factor that affects public health is the issue of cross-contamination. Repackers often handle several API’s, some of which may include strong doses of testosterone, estrogen, and even opioids. If these powdered APIs manage to touch another, they could cause significant issues for the consumer. Some repackers have failed to conduct cleaning validation studies, and others have not provided verification of their studies. This puts the public at risk of adverse health effects that arise from mixing medicines or ingesting a non-prescribed API.
When there are these lapses in supply chain oversight, problems in both pharmaceutical distribution and public health can emerge. These conditions imply that industry workers are not receiving the proper training they need to protect consumer health. As long as there are effective training options in place, companies should consider having their workers take regulatory compliance training programs more consistently to avoid putting consumers at risk of harm.
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