GxP Lifeline
3 Ways CMOs Are Looking to Digital Technology to Improve Collaboration
Rising demand for contract manufacturing organizations (CMO) necessitates growth to new locations throughout the U.S. and across the globe. The result of this expansion is increased production, but also a more complex supply chain, which requires digital collaboration with brand owners. A recent MasterControl trend brief examines three ways contract manufacturing organizations are looking to digital technology to improve collaboration, and is summarized here.
#1 Improved Quality Product Development and Quality
Accenture reported 78% of life science companies indicated they want to improve collaboration within their quality management processes with their CMOs. (1) This level of collaboration and transparency is only available through digitization because:
- Going digital and transitioning away from a pen-and-paper approach to production records eliminates common human errors.
- Using digital production records makes it possible to conduct a review by exception, which saves a significant amount of time and gets products out the door faster.
- Providing a single source of truth for quality and manufacturing eliminates friction because both departments have access to the information needed to be successful in their work.
Digitization brings tangible results that are important to both CMOs and brand owners. MasterControl customer Legacy Pharmaceutical Packaging, LLC utilizes MasterControl’s Manufacturing Excellence™ electronic production records and reduced quality review from 2-3 hours per production record to 10-15 minutes per production record.
#2 Reduced Variability and Improved Visibility
Frequent, comprehensive customer audits make visibility a top priority for CMOs. A recent survey of product owners showed 64% conducted an onsite inspection of their CMOs’ facilities within the last year, while 21% have done so within the last five years. (2) CMOs must demonstrate to brand owners they are adhering to product requirements while keeping them informed about product status and delivery times. In a disconnected environment with incomplete and inaccurate information, it’s impossible to supply brand owners with required information. Visibility comes through connectivity that is only possible with digitization. Both CMOs and brand owners can operate using information gleaned from the same source, ensuring both parties have accurate, complete data available to them in real time.
The Accenture study reiterates the importance of visibility as a means for managing risk and knowledge across the entire product life cycle in complex supply chains. The study explains, “This is difficult to achieve without a strong process for exchanging data and knowledge between CMOs and their customers, particularly for complex drugs where the original process development was entirely managed by the CMO who may have developed tacit knowledge of the process (and the [critical process parameter/critical quality attribute] correlations). If this knowledge isn’t comprehensively captured, curated, analyzed and shared with the client, the risk associated with changing the process will be very high, especially for complex products with large numbers of CQAs.”
#3 Improved Cost Reduction and Increased Revenue
To continue succeeding in an increasingly digital world, CMOs need to put a modern infrastructure in place. The benefits will include cost reduction and increasing revenue as well as the following:
- Shortening review and release.
- Ensuring operators are properly trained on frequently changing production lines.
- Streamlining the release and shipment of product for greater cash flow.
Ultimately, the demand for CMOs makes it critical that they collaborate with brand owners. Using manual, paper based systems is a dated, error-prone process that creates silos. Storing information in a connected, digital environment allows for the manufacturing of complex, high-quality products that meet regulatory requirements.
References
- “Dare to be Different: It’s time to revamp collaboration in life sciences manufacturing,” by Anne Marie O’Halloran, Barry Heavey and Greg Ciccarelli, Accenture, 2019. https://www.accenture.com/_acnmedia/PDF-98/Accenture-Life-Sciences-Dare-to-Be-Different-Contract-Manufacturing.pdf
- “2020 Contract Manufacturing Survey,” by Sean Moloughney, Contract Pharma, 2020. https://www.contractpharma.com/issues/2020-03-01/view_features/2020-contract-manufacturing-survey/
Dale Thompson is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. Her areas of expertise are pharmaceuticals and manufacturing. Thompson’s varied career includes extensive work in grant writing and journalism as well as crafting content to highlight the work of biology professors and paleontologists. She has a bachelor’s degree from Evergreen State College and a master’s degree in professional communication from Westminster College.
