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FREMONT, CA: Medication scarcity comes along with a considerable cost to pharmaceutical organizations, loss of revenue, and brand reputation, which can be constant and determined threats to a business in such cases. Drug deficiency surpasses the pharmaceutical industry to encompass every aspect of healthcare. A patient-care sector that is focused on the benefits of its patients, the unavailability of medication possesses a threat to the patient’s quality of life.
Therefore, when the providers fail to provide safe practices, proper drug therapy, and provide harmful substitutions, they compromise a provider’s potential to care for the patients efficiently. As per an assessment held by the American Society of Health-System Pharmacists (ASHP) in 2018, manufacturing is one of the most noted causes of medication scarcity. Production is considered as the most expensive and process-intensive step in the supply chain, following the approval of the drugs.
With every aspect of the healthcare and life science ecosystem, regulatory compliance is the primary apprehension for the pharmaceutical companies. Any drug manufacturing facility that undergoes constant and rigorous inspections and fails to succeed brings negative impacts as the facility output. So far, FDA inspections were repetitive and time-consuming, with restricted staff and obsolete inspection methods.
A New Inspections Protocol Project (NIPP) was created in 2015 for the increasing complexities of the pharmaceutical landscape and technological advancements, with a mission to bring facility inspections into the digital era.
With the growth of product expenses and patient demands rising steadily, it is difficult for the medication manufacturers to control batch variation. The unsuccessful inspection makes the ability of the company drive limited revenue but also process equipment changes, and added inspection costs also get provoked. To alleviate such quality issues, medication manufacturers need to increase the level of transparency and monitor the offshore production facility. The automated AI-driven processes, inclusive of the use of robotics, can offer more control as the human error is separated as a feature, and smart systems can self-regulate for different criteria.