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White Paper: Addressing The Pharmaceutical Quality Testing Bottleneck


The demand on drug manufacturers to get operations right has never been more urgent. Most agree the myriad of challenges the Pharma industry faces in the market today will continue to mount in the coming years as companies work to fill product pipelines and leverage the torrents of information generated by commercial operations to win in the marketplace. As a result, life-science com¬panies are seeking new ways to optimize product lifecycle processes from early stage development to commercial scale manufacturing.

Pharma industry leaders are in¬creasingly turning to information-based technologies and paperless, automated informatics platforms to manage complex quality and compliance regimes. This also includes laboratory operations that are often considered a bottleneck but still needed to support overall product quality and proactive compliance.

Whether it’s Research and Development at a bio start-up or Quality Assurance/Quality Control programs at an OTC antihistamine plant, an integrated platform of informatics systems that automates routines and limits paper-based data gathering and storage is an industry best practice that is transforming these operations. Highly developed Laboratory Execution Systems (LES), Electronic Laboratory Notebooks (ELN) and Laboratory Information Systems (LIMS) are providing drug manufacturers and de¬velopers new opportunities to manage risk and eliminate efficiency drains as they strive to manage ever-chang¬ing business ecosystems.

Quality testing programs are long recognized not only as a focal point of compliance, product quality and risk management, but a choke point as well, because the success of an organization’s overall operations are so dependent on quality testing and the efficiency of its processes required to administer work and manage the information and documents effectively.


The main issue addressed by this white paper is the question of whether Pharma’s operational managers and leadership feel quality testing is, in fact, a bottleneck? In order to validate and quantify the discontent observed with executing quality testing operations, BIOVIA sought to gain a better understanding of the industry’s own perception of the efficiency and effectiveness of quality testing programs.

In collaboration with Pharmaceutical Manufacturing brand, BIOVIA surveyed approximately 100 industry-leading pharmaceutical, biopharmaceuti¬cal, contract and generic pharmaceutical manufacturers to gauge their perceptions of the pain points associated with quality testing regimes, as well as to better under¬stand the current state of quality testing programs with¬in pharmaceutical and biopharmaceutical operations.

Ultimately, over 120 QA/QC, manufacturing, opera¬tional and compliance executives completed the survey. Their responses revealed the challenges they face managing these operations effectively and how they and their organizations are working to meet the needs of the internal constituencies that rely so heavily on quality testing programs.

Is quality testing considered a bottleneck by Phar¬ma’s operations leadership and is it a high priority to address? These two questions and responses are closely related. Of those surveyed, nearly two-thirds respond¬ed that their current quality testing process is indeed perceived as a bottleneck, and nearly three-quarters (72 percent) said addressing the bottleneck is a high priority for their organizations. It’s interesting to note more respondents felt it was an issue to address as opposed to those who responded they perceived it as a bottle¬neck – but that result may have more to do with the order in which the questions were asked rather than the disconnect it seems to suggest.

Regardless, it’s clear that a majority of responders agree there is a bottleneck and that their organizations are making it a priority to unknot its constraints and free up these important re¬sources so their QA/QC teams can effectively fulfil their multifaceted roles in support of operations.

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