Within the past year, regulatory issues and violations at CMOs have delayed the launch of promising pharmaceuticals. Image Source: Flickr User: ChemieBW
Life science firms are expanding well beyond their borders to increase production, and contract manufacturing organizations (CMOs) are popping up everywhere to take on this task. Over the past few years, CMOs have proven to be an extremely critical component to the industry. Currently, though, there are gaps that allow information to fall through the cracks, leading to delays. To enable better communication, a comprehensive quality management system is needed to ensure that CMOs are remaining compliant with regulations as to avoid violations, leading to the cessation of working with a pharmaceutical candidate.
Where Pharmaceutical Candidates Perish
Many small and mid-size pharmaceutical companies lack the financial resources to build their own manufacturing facilities, so CMOs have allowed these smaller companies to take their place alongside global bio/pharma companies. Currently, roughly 80% of all products approved by the FDA for small pharmaceutical companies are manufactured in CMOs, as well as 50% FDA approved products from mid-size companies.1 In recent years, a number of these companies have encountered issues where candidate drugs, for any of a number of failures during the process, have not made it to clinical trials or to market. Here are some things that pharmaceutical companies have identified as important when looking at outsourcing:
- Presence of a Quality culture
- CMO commitment to FDA vs. client quality needs
- Quality records
- Process by which the CMO introduces a new product into their facility2
Many of these can be more easily managed and tracked by stepping away from paper documentation and toward a comprehensive quality management program. By electronically tracking the product, perhaps in terms of batch/lot, pharmaceutical companies can keep a record of where and when quality has slipped to ensure that problems in the process are corrected, avoid delivering substandard product out for consumers. Additionally, when changes to procedure are implemented, there are fewer concerns about ensuring that the manufacturing facility has complied. An integrated system allows both researchers and manufacturers to have immediate access to the most up-to-date information regarding process and quality.
Consistency is Key
For small to mid-sized pharmaceutical companies, the discovery and initial development process is generally conducted in-house, where their own scientists to take the lead compound to a place where it is either ready for clinical trials or store shelves. CMOs are the key piece in production that allows for a higher volume of manufacture. A biopharma company’s relationship with their CMO is key to ensuring that their product is made consistently and compliantly. Poor communication between a CMO and a bio/pharma company can lead to the loss of a promising candidate and, subsequently, a great deal of R&D investment. Although there are variations that depend upon portfolio and the companies respective sizes, there are a few common threads that need to be addressed to keep this from happening:
- Consistent quality processes and procedures: The processes created and used in the lab to produce the initial product need to be maintained and scaled accordingly. Often, these procedures are found on paper in lab notebooks. Procedures need to be translated to a common digital platform that will allow for global editing and modification in the event of needed change. This will reduce non-value-added manual tasks and errors to improve efficiency.
- Adherence to demanding quality procedures: Moving away from a paper process and towards innovative lab software is the first step the ensuring standardization of quality processes. By standardizing workflows, both in protocol and in general manufacturing practice, it is more likely that manufacturing staff will be aware of what those procedures are and more likely that they will adhere to standard practices.
- Quality documentation control: This is an added layer of protection which ensures that the two aforementioned points are being followed. Quality documentation is the proof that the procedures are working, that the staff are producing products which are compliant with regulations and that those products are consistently of high quality. Modern software that takes all of the compliance guides into account—such as FDA 21 CFR Part 11—would be ideal, as it makes the overall process more efficient.
All of these features would be amazing on their own, but they’re far better together. BIOVIA One Quality provides all these features, and much more.Through better process, product and compliance management, One Quality allows pharmaceutical companies to increase efficiency and reduce costs. By ensuring that products are made correctly, through compliance checks and preemptive action, pharmaceutical companies can do away with major concerns over recalls or failed candidates. Please contact us today to learn more about how our software options can support the efforts of your lab.
- “What’s next for the CMO Industry?” August 2, 2016, http://www.pharmtech.com/what-s-next-cmo-industry-0 ↩
- “Top (Secret) Quality Concerns For Selecting CMOs: How Important Are Records?” September 27, 2016, http://www.outsourcedpharma.com/doc/top-secret-quality-concerns-for-selecting-cmos-how-important-are-records-0001 ↩