Pharmaceutical Quality Control
The developed world relies on the availability of modern medicine for daily life. The COVID-19 pandemic has served as a stark and sobering reminder that we are accustomed to low mortality rates due to disease. Rates of death and illness that would have simply been considered a normal part of life one hundred years ago are no longer acceptable.
Our reliance on—and faith in—today's pharmaceuticals as a routine part of health care is underpinned by the guarantee that the medicines being administered meet certain standards of quality. There's simply no question that Pharmaceutical quality control is critical to modern medicine.
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Today's standard: purity and legitimacy of medicines
The developed world is accustomed to having a high degree of accountability from pharmaceutical manufacturers, whether they are a global brand, a generic manufacturer, or a one-product company with a breakthrough medication in it final clinical trials. Agencies such as the Food and Drug Administration of the United States, the European Medicines Agency of the European Union, and the National Medical
Products Administration in China serve as gatekeepers for the largest pharmaceutical markets, setting stringent quality requirements for medicines.
In order to be granted regulatory approval by these agencies, a pharmaceutical manufacturer must be able to consistently produce the medicines they have permission to sell.
Regulatory considerations aside, the consequences of poor pharmaceutical quality control can be dire. Prior to the establishment of pharmaceutical regulatory agencies, there were countless instances of poisonings due to poorly formulated drugs.
Even with the creation of regulatory bodies around the world to prevent further tragedies, the lack of adequate pharmaceutical quality control can still cause human suffering. Most famously, the drug thalidomide, prescribed as a drug to treat morning sickness, is safe so long as the purified version of one of two stereoisomers is used. The mirror of the safe molecule, however, causes birth defects and miscarriages. Poor pharmaceutical quality control led to thousands of cases of phocomelia, in which a child's limbs fail to develop normally.
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Testing across the chain
A health system's pharmaceutical supply may rely on multiple, interdependent facilities that are involved in the manufacture of pharmaceuticals. A factory or lab may produce bulk quantities of a drug that is then either further refined or mixed with other ingredients at a different facility. Each part of the pharma supply chain must comply with pharmaceutical quality control protocols. Regulatory agencies may stipulate different controls depending on the type of facility. For example, a bulk processing facility that produces barrels of antibiotics doesn't need to comply with blister packaging laws, but will have to follow rules regarding bulk storage.
Pharmaceutical quality control relies on thorough testing of randomized samples from the pharma supply chain. A regulatory body will take samples of pharmaceuticals at different facilities and have them tested in laboratories. This lets regulators pinpoint issues in the pharmaceutical supply chain and help determine where they are occurring.
Cutting down on counterfeiting
One of the greatest threats to pharmaceutical supply chain security has been the advent of counterfeit medications. Knock-off medications and fake pharmaceuticals can lead to negative health consequences and even death.
Sampling at multiple points in the supply chain can identify where a knockoff medication entered the stream. It may be easier to swap in barrel of fake antibiotics before it is packaged into pills, so it is crucial to check at each step of the process.
To combat the rise in fake drugs, more than fifty countries have pharmaceutical serialization requirements that stipulate manufacturers place a serial number on every saleable unit of medicine. These laws aim to make it possible to track every package of medicine through the entire supply chain. This practice severely curtails opportunities for adulteration or substitution, significantly increasing the level of pharmaceutical quality control available to health systems.
FAQs: How do pharmaceutical serialization requirements help with pharmaceutical quality control?
How do pharmaceutical serialization requirements help with pharmaceutical quality control?
Pharmaceutical serialization requirements and pharmaceutical serialization track and trace legislation aim to produce an uninterrupted audit trail for every saleable unit of medication. The result is a wealth of data that can link every unit of medicine through the pharmaceutical supply chain.
Why is pharmaceutical quality control so critical?
The quality of pharmaceuticals can have enormous impacts on human well-being. Problems in production, transport, and storage that alter the efficacy of a medicine can result in patients experiencing negative outcomes and even death.
What makes it particularly difficult to appraise the quality of pharmaceuticals?
Pharmaceutical compounds are often novel substances that have very specific chemical structures. There may be no easy way to tell at the time of administration whether the medicine is as described—and having to test each dose before giving it to a patient would be a significant drain of resources.
How do counterfeit pharmaceutical drugs affect the pharmaceutical supply?
Counterfeit pharmaceutical drugs present significant problems for health systems. Some knock-off drugs actually contain the active ingredients as claimed, but unscrupulous counterfeiters may be packaging other substances instead of therapeutically efficacious drugs. This has led over 50 governments to institute track and trace requirements for every saleable unit of medicine distributed within their jurisdictions. Attaching serial numbers to every individual unit of medicine enables caregivers and patients to ascertain the provenance and path of the substances they are using for treatment.
Do generic pharmaceuticals have to follow the same standards as name brand drugs?
Yes, the regulatory standards for pharmaceuticals are just as high for generic drugs as for those manufactured under exclusive patent.