Virtual ExperienceApril 23, 2018

Increased Regulatory Scrutiny Demands Better Process Understanding

The FDA proposed standards for quality metrics and followed that up with…
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The FDA proposed standards for quality metrics and followed that up with guidelines covering data integrity and cGMP compliance. The latter, in particular, has highlighted a string of high-profile quality violations during the drug manufacturing process in overseas facilities. Given that a third of generic small-molecule drugs consumed in the United States are made in India,[1. “Regulators step up scrutiny of drug makers,” September 14, 2016,] these quality issues are a cause for concern. As drug companies continue to expand their organizations across the world, they must ensure that their manufacturing facilities maintain high quality; otherwise, they risk punitive actions from regulatory agencies. The integration of their process and data quality systems via comprehensive digital solutions will help them reach these goals.

Poor Manufacturing Quality Leads to Regulatory Action

From 2011 to 2016, twenty-seven drug manufacturing plants in India received warning letters from the FDA for data integrity violations. In addition, fifteen of those plants also received import alerts. Beyond these negative repercussions, poor manufacturing quality has serious consequences for pharmaceutical organizations.

  • Market restrictions: Import alerts mean that small-molecule drugs manufactured by a specific company may lose access to lucrative markets. For instance, the United States is the largest pharmaceutical consumer in the world. As a result, placing limits on drug exports can severely impact a company’s margins.
  • Delayed approvals: Warning letters often require that affected firms address observed violations. Until these discrepancies are corrected, regulatory agencies may refuse to approve any future products, leading to delayed launches.
  • Issuing of fines: Depending on the severity of observed violations, regulatory agencies may issue fines. An insufficiently vigilant drug manufacturing process may result in as much as $500 million in citations.

Avoiding regulatory action isn’t the only reason to remain vigilant about the drug manufacturing process. Just as poor quality results in negative repercussions, instilling confidence in quality standards leads to positive accomplishments such as receiving approval to expand manufacturing capacity. [2. “PaizaBio gain approval from CDFA to expand capabilities and capacity in China,” October 3, 2016,]

Digital Solutions Support Better Product Quality

The drug manufacturing process requires consistency. Variability can lead to quality issues that can affect the final product. The last thing a drug company wants to face are the consequences of a poor quality product resulting from deviations. [3. “India loosens drug oversight as more Indian companies make substandard medicines,” October 11, 2016,]

One way to boost manufacturing consistency and reduce variability is by unifying process and data quality systems through the implementation of a comprehensive digital solution. The advantages of adopting such as a strategy include:

  • Performance monitoring: As pharmaceutical organizations expand across the world, the ability to monitor the manufacturing process across facilities becomes more important. Facilities will be able to track crucial production processes and ensure that they are falling within acceptable parameters. And by collecting the quality data associated with these processes, organizations will be able to produce the necessary compliance records and reports easily.
  • Reduction of variability: Facilities will be able to identify when manufacturing processes deviate from acceptable quality standards. Because the drug manufacturing process is being monitored in real time, organizations can pinpoint the root cause of any deviations and correct them earlier. This minimizes the risk of releasing poor quality products that can impact the company’s margins and reputation.
  • Data and Process Collaboration: The rise of multinational facilities means that organizations need the ability to share contextual data and process information across the world. By doing so, companies will be equipped to make important decisions faster with the best knowledge and insights. They can determine if the manufacturing process needs to be improved or altered, and if those changes need to be instituted in other facilities.

While increased regulatory scrutiny has placed additional focus upon the drug manufacturing process, life sciences organizations can meet tightening standards by reducing variability. To accomplish this goal, pharmaceutical companies need to integrate their process and data quality systems into a unified system. By doing so, they can maintain high manufacturing and product quality, thereby navigating today’s highly regulated market. Find here more information how BIOVIA can help to ensure quality and increase productivity by streamlining and better tracking workflows and batch information.

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