GxP Lifeline
Three Tips for Pharma Picking a CMO
For pharmaceutical companies, partnering with a contract manufacturing organization (CMO) is an attractive option because, among other advantages, they provide you with access to the latest technology, help you achieve rapid scalability, reduce overhead costs, and more. Collaborating with a CMO offers significant benefits, but you’re also relying on them to maintain your impeccable standards for product quality. To ensure you choose a CMO that will meet expectations, follow these three tips.
1. Confirm your CMO has a modern manufacturing solution.
If a contract manufacturer isn’t using a modern manufacturing solution, you need to reconsider. When you encounter a CMO still using paper on the shop floor, this is a red flag for several reasons.
- The U.S. Food and Drug Administration (FDA) is increasingly focused on data integrity, and it plays a central role in the drug approval process. 1 Because paper-based records are prone to human error, a lack of data integrity can hinder your compliance efforts.
- Paper-based processes are inefficient and can result in significant delays. As just one example, when a post-production review is conducted line by line, page by page, your finished product may sit on the shop floor for weeks. It won’t be ready to ship until the review is completed.
- Paper documentation and processes can’t scale to help you meet demand (see point 3).
Digitization helps address each of the issues discussed above. By using a digital, connected manufacturing solution, CMOs are aligning themselves with FDA priorities, which streamlines compliance efforts. Quality is improved because data entry errors are fixed in real time, and they can’t impact other aspects of production. These efficiency gains optimize the production process, and you can deliver a high quality, compliant product to market faster.
2. Ensure your contract manufacturing organization provides visibility
A common concern among the industries partnering with CMOs is visibility. A survey conducted by Accenture found that 60% of respondents struggle to get real-time inventory or manufacturing visibility, and almost 40% said they lack control over product quality. 2 The CMO you choose should be prepared to build your trust by providing transparency during production.
They need to always have the following information readily available:
- Accurate, complete data showing your product requirements are being met.
- The production status (i.e., exactly where your product is on the shop floor).
- The delivery time.
As with the point above, it is necessary for a CMO to have a digital manufacturing solution because it can allow them to share the relevant data they collect throughout the production cycle quickly and completely. This information will confirm your production requirements are being met, and the contract manufacturer will have access to real-time dashboards, so you know the current status of your product, which includes the delivery time.
Because it’s not uncommon for CMOs to be located in different parts of the world than you, a best practice is for CMOs to store digital information in a central location. This ensures that all the key stakeholders have 24/7 access to the most up-to-date information from anywhere in the world.
3. Know your CMO can scale to meet your needs
As a pharmaceutical company, you may need to scale up quickly to meet an increase in demand or scale down to produce small batches. Choose a flexible CMO that can adjust to cater to your needs.
If you need to scale rapidly, a CMO with a robust digital manufacturing solution is adaptable and provides the agility you require to respond to growing market demand. If they have the right capabilities, a CMO should be able to scale up rapidly and assist you with high-volume manufacturing.
Perhaps you’re a pharmaceutical company that needs to do the opposite because you’ve recently entered the growing field of personalized medicine, and you’re in search of a CMO that can scale down to make small batches or a batch of one. The CMO you choose to partner with should have expertise in high-mix, low-volume manufacturing and be capable of creating individualized treatments.
Regardless of which direction you need to scale, find a CMO with an efficient process in place for accurate change management. Some CMOs have a master template for each product variation, but this approach isn’t sustainable, and one mistake could ruin an entire batch, which wastes time and materials while adding unnecessary expenses. A digital solution saves time and reduces errors by streamlining change management by allowing product variations to be managed through a single master template.
Conclusion
Your pharmaceutical company undoubtedly has unique requirements that need to be met by a contract manufacturer. To ensure that you find the right one, a good starting point is to narrow down which CMOs you may work with by identifying and choosing from the ones that have a modern manufacturing solution, offer transparency throughout the entire production cycle, and can scale quickly.
References:
- “Remarks by Acting Commissioner Janet Woodcock to the FDA Pharmaceutical Quality Symposium 2021: Innovations in a Changing World,” FDA website, October 26, 2021.
- “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.
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.
