Partnerships with contract manufacturing organisations (CMOs) are vital for staying competitive in today’s pharmaceutical industry. Pharma contract manufacturing partnerships are ideal for helping companies cut overhead costs, scale quickly, and devote more attention to their core competencies. CMO partnerships bring measurable benefits, but aligning your CMOs with your organisation’s quality standards and compliance requirements can be a huge challenge.

By following the three steps highlighted below, you can narrow down the field of prospective pharma contract manufacturing partners and choose the CMOs most capable of helping your organisation achieve big goals, meet regulatory requirements, and deliver high-quality products to market quickly.

1. Ensure Your CMOs Have Digitally Optimised Manufacturing Processes

Before partnering with a CMO, find out if they’ve implemented a proven, purpose-built contract manufacturing software solution that optimises production processes. Without a digitised manufacturing execution system (MES), a CMO can’t offer the speed, flexibility, and process optimisation you’d get from a digitally mature, modernised CMO.

A CMO that still relies on manual, paper-based processes poses three major concerns:

1. Paper slows down every process in which it is used, and its inefficiencies cause unnecessary delays that you can’t afford. For example, if your CMO conducts post-production reviews by going line by line and paper page by paper page, the finished product will sit idle longer, unable to be shipped until laborious reviews are completed.
2. Manual data entries made on paper records are prone to error. Inevitably, they lead to data integrity lapses that undermine your compliance efforts. Regulators like the U.S. Food and Drug Administration (FDA) pay close attention to pharmaceutical companies’ ability to establish and maintain data integrity, which can be a dealbreaker in the drug approval process.¹
3. Paper-based processes and paper documentation aren’t scalable. When demand rises, they’ll only impede your contract manufacturing management efforts.

Be aware that there are contract manufacturing software solutions on the market that have been specifically engineered to meet the needs of life sciences manufacturers. These purpose-built systems empower CMOs to eliminate paper and avoid the common production issues highlighted above. Pharma contract manufacturing organisations can help you optimise compliance activities if they’re equipped with digitally connected contract manufacturing templates. Contract manufacturing software solutions also enhance product quality by making it possible to fix mistakes faster – and even avoid some altogether. The bottom line is that modern digital tools put your CMOs in a better position to meet your expectations, and those of the agencies that regulate your products as well.

2. Ensure Adequate Visibility Into Your CMOs’ Production Activities

Whether production is conducted in house or by a contractor, visibility into production activities is a major concern in pharma contract manufacturing. Accenture research recently revealed that 60% of manufacturers in the life sciences have difficulty accessing real-time inventory or manufacturing visibility, and nearly 40% reported a lack of control over product quality.² Although production data visibility can be hard to achieve – and even harder maintain – you should insist that it is something your CMO partners are capable of providing.

Your pharma contract manufacturing partners should be able to readily provide information like:

• Accurate, up-to-date, and complete data that demonstrates the CMO’s ability to meet product requirements.
• Production status indicators showing precisely where a product is at any point in production.
• Mutually-agreed-upon expected delivery times.

Good contract manufacturing management practices entail that your data must be centralised, even though it’s likely that your CMOs are geographically dispersed and not near your primary site. A reliable contract manufacturing software solution can give decision-makers and stakeholders access to up-to-date information from anywhere and at any time. When a CMO is capable of digitally transferring relevant, comprehensive data that has been collected throughout the production process, they’re able to easily and instantaneously provide assurance that production requirements are being met.

3. Ensure Your CMOs Can Provide the Scalability You Need

When demand goes up, pharma companies must scale up quickly to meet the rising need. In other cases, such as rapidly growing fields like cell and gene therapy and personalised medicine, a company may need a CMO that can scale down to make smaller batches. It’s critical to have confidence that your pharma contract manufacturing partners have the requisite adaptability enabling them to adjust appropriately to the dynamics of your organisation.

If you need to scale rapidly, partner with a CMO equipped with robust contract manufacturing software that facilitates adaptability and is agile enough to respond to market fluctuations and industry and organisational demands. Whether you want to scale up or down, you need a CMO with efficient and effective change management processes. Some CMOs have a master template for each product variation, but that isn’t a sustainable tactic. In those instances, a single mistake can ruin an entire batch, which wastes time and materials and leads to unnecessary expenses. A modern solution that allows product variations to be managed through a single contract manufacturing template optimises change management, reduces errors, and saves everyone time.

Conclusion

All pharma companies have unique requirements, and it’s much easier to meet them when you can depend on purpose-built contract manufacturing software. To avoid contracting with the wrong partner, first identify the CMOs that have implemented a modern contract manufacturing software solution so you’re sure you can get the visibility, adaptability, and scalability you need to stay competitive and meet the demands of compliance.

References:

1. "Remarks by Acting Commissioner Janet Woodcock to the FDA Pharmaceutical Quality Symposium 2021: Innovations in a Changing World,” FDA website, October 26, 2021.
2. "Dare to be Different: It’s time to revamp collaboration in life sciences manufacturing,” by Anne Marie O’Halloran, Barry Heavy, and Greg Ciccarelli, Accenture, 2019.