The pharmaceutical supply chain continues to experience product recalls, drug shortages, and supply disruptions due to unsatisfactory quality in manufacturing, according to the FDA. 1 Since the COVID-19 pandemic, quality management issues in the pharma and biopharma spaces have suffered even more.
In fact, in 2022, the FDA issued more than 130 recalls attributed to temperature abuse, 100 recalls caused by products being stored outside the appropriate temperature conditions, and 51 recalls associated with manufacturing using a contaminated excipient that had already been recalled by its supplier. 2 These recalls— along with numerous smaller instances— come with a hefty price tag. The process of addressing these issues is time-consuming, expensive, and requires patience to correct the problem and prevent its recurrence. This does not even account for the wasted products and damage done to the company’ s reputation.
As biopharma companies embrace digital transformation, many are turning to quality management solutions. These platforms aid in managing product quality, ensuring they meet regulatory standards. But the advantages extend beyond just compliance. It’ s no surprise then, that the market valuation for pharma quality management systems will hit nearly $ 4 billion by 2030. 3
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CONTINUOUS IMPROVEMENT WITH QUALITY MANAGEMENT
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The pharmaceutical supply chain continues to experience product recalls, drug shortages, and supply disruptions due to unsatisfactory quality in manufacturing, according to the FDA. Since the COVID-19 pandemic, quality management issues in the pharma and biopharma spaces have suffered even more.
In fact, in 2022, the FDA issued more than 130 recalls attributed to temperature abuse, 100 recalls caused by products being stored outside the appropriate temperature conditions, and 51 recalls associated with manufacturing using a contaminated excipient that had already been recalled by its supplier. These recalls – along with numerous smaller instances – come with a hefty price tag.
The process of addressing these issues is time-consuming, expensive, and requires patience to correct the problem and prevent its recurrence. This does not even account for the wasted products and damage done to the company’ s reputation.
As biopharma companies embrace digital transformation, many are turning to quality management solutions. These platforms aid in managing product quality, ensuring they meet regulatory standards. But the advantages extend beyond just compliance. It’ s no surprise then, that the market valuation for pharma quality management systems will hit nearly $ 4 billion by 2030.
QUALITY MANAGEMENT: A REGULATORY MANDATE
In the life sciences industry, and in biopharma especially, quality management procedures are mandatory. Regulatory bodies rigorously inspect that approved procedures are in place; staff are trained and usage is confirmed. Meeting regulatory requirements is crucial for companies to secure or maintain the license to manufacture and / or sell products. �
CONTINUOUS IMPROVEMENT WITH QUALITY MANAGEMENT BIOVIA’ S BIOPHARMA QUALITY MANAGEMENT ANALYST SOLUTION
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