Manufacturers have to invest in advanced technologies like the Internet of Things (IoT) for monitoring equipment and artificial intelligence (AI), in order to address supply chain issues and take the necessary measures.
FREMONT, CA: Medication shortage comes along with a substantial cost to pharmaceutical organizations, provide loyalty, loss of revenue, and brand reputation poses solid and determined threats to a business. Drug shortages surpass the pharmaceutical sector to encompass all the aspects of healthcare. Being an industry that is focused on the benefits of patient-led care, unavailability of medication risks a patient’s quality of life. Hence when the providers are not able to provide unsafe practices, proper drug therapy and potentially harmful substitutions compromise a provider’s ability to care for the patients effectively. According to an assessment conducted by the American Society of Health-System Pharmacists (ASHP) in 2018, manufacturing is the most noted cause of medication shortages. After the approval of the drug, manufacturing is the most costly and process-intensive step in the supply chain.
Updated and Ongoing Pharmaceutical Compliance
Along with all the aspects of the healthcare and life science ecosystem, the primary concern for the pharmaceutical companies in regulatory compliance. A drug manufacturing facility has to undergo constant and rigorous inspections, and failing inspection will lead to delays, negatively impacting the facility output.
Until now, FDA inspections were monotonous and time-consuming, with limited staff and outdated inspection processes.
They followed the manual process, which was subjected to human errors like unsafe handling techniques, differing results from inspector subjectivity, and overlooked microscopic particles and contaminants.
To tend to the increasing complexity of the pharmaceutical landscape and technological advancements, a New Inspections Protocol Project (NIPP) was created in 2015 with an aim to bring facility inspections into the digital age.
Reduce Cost to Provide Care
With the rise of product cost and patient demand rising continuously, it is difficult for the medication manufacturers to control batch variation. Failed insection not only makes the company’s ability to drive revenue limited but also process equipment changes, and additional inspection costs can also be provoked. To mitigate this quality issue, medication manufacturers should increase the level of visibility and monitoring in the offshore production facility. The automating process through AI, inclusive of the use of robotics, can provide further control as the human error is removed as a factor, and intelligent systems can self-regulate for distinct criteria.
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