However, the innovation does not stop at manufacturing. To ensure that these high-quality therapies then keep pace with demand and get delivered safely and effectively to patients, pharmaceutical companies need trusted partners — from the early stages of drug discovery through to process development and market entry.
Steven Falcone, Senior Director of Compliance and External Engagement, Pharma Services, at Thermo Fisher Scientific, explains why pharmaceutical companies often turn to contract development and manufacturing organisations (CDMOs) for an advantage.
CDMO partners provide the knowledge and experience to map out a drug’s journey from discovery to commercialisation.
What’s more, those with state-of-the-art technologies and a dedication to manufacturing excellence can support their pharma partners beyond the immediate scope of product development with scalable solutions for long-term success.
In fact, embracing innovation to accelerate key areas such as quality harmonisation not only impacts the development and manufacturing of one drug or project but can also greatly influence the entire industry.
Enabling accelerated market entry for safe and effective therapies, the harmonisation of quality standards, procedures and practices throughout a CDMO’s facilities is critical to the overall health of the pharmaceutical supply chain.
It is important for pharmaceutical companies to seek out a CDMO partner that is well versed in these industry standards and demonstrates proven reliability and resiliency; they are essential elements of supply chain management and pharmaceutical manufacturing.
Creating uniformity and ensuring regulatory compliance with quality frameworks
For CDMOs with a global presence, quality harmonisation is imperative. It creates uniformity throughout quality control processes, guarantees standard operating procedures and establishes good manufacturing practice (GMP) quality systems so that each facility adheres to the same high standards.
Together, this lays the groundwork for consistent product quality and efficiency, irrespective of location.
Compliance and regulatory standards are core components of quality systems throughout the manufacturing process. With sites around the world, CDMOs must meet the compliance and regulatory demands of each facility’s respective region.
Unified quality systems are fundamental in this context as they provide a cohesive framework to seamlessly integrate regulatory compliance.
Although the requirements of these regulations may be complex, adherence is critical for pharmaceutical manufacturing operations to ensure that drugs are produced, distributed and marketed in accordance with global safety standards.
Maintaining quality via technology transfer
Technology transfer is a key mechanism in terms of achieving uniformly high-quality products throughout the continuous manufacturing of a product. In some instances, pharmaceutical companies may need to scale-up production at one facility or transfer it to another one.
If the pharmaceutical company works with an outsourcing partner, then the CDMO can relay knowledge, procedures and technology between sites.
This ensures that the high standards of quality and compliance are consistently replicated, regardless of location and scale of production during the manufacturing process.
The impacts of oversight and organisational culture in quality manufacturing
Whereas ensuring compliance and technology transfers are important aspects for quality harmonisation within manufacturing, the human element remains a critical aspect of success.
With oversight and a strong organisational culture focused on quality assurance, CDMOs can confirm that their workforce and employees are aligned with business goals and objectives. This drives continuous improvement and monitoring of pharmaceutical manufacturing processes.
Quality harmonisation’s impact on supply chain resiliency
A CDMO’s ability to ensure quality uniform systems, regulatory compliance, effective technology transfers and strong organisational culture play a major role in the overall health and resilience of the pharmaceutical supply chain. Together, these components play important functions through the following.
- Standardisation and prediction: CDMOs must guarantee that products are manufactured with the same level of quality regardless of where the product is physically produced, reducing variability throughout production. Forecasting and planning is critical to supply chain management as it lowers the impact of unexpected disruptions.
- Efficient risk management: Resilience within the manufacturing supply chain relies on a consistent quality framework throughout all production locations. This allows for proactive risk management and the assurance that any potential quality issues are solved quickly, limiting impact on the overall supply chain.
- Enhanced agility and flexibility: There are often situations when CDMOs must shift drug production to a different site. This can happen for many reasons, including regulatory changes, geopolitical issues or natural disasters. Regardless of the cause, harmonised quality systems ensure that these manufacturing transitions occur seamlessly, limiting supply chain disruptions.
- Stakeholder trust: As with any business, fostering trust is critical to an organisation’s success. Harmonised quality systems will increase stakeholder confidence in the CDMO’s ability to deliver consistent and high quality, crystallising long-term relationships.
- International compliance: CDMOs that have created harmonised quality processes that are compliant with regional and global regulations can navigate international operations with ease. This is critical to ensure that the supply chain is not interrupted by regulatory changes, especially for organisations who are manufacturing abroad.
- Data-driven insights for supply chain optimisation: Continuous data collection and analysis is critical to implement a consistent quality framework. This allows for CDMOs to forecast trends and demand, streamline logistical tasks and stay on top of technological advancements that could allow for innovation.
CDMOs with a harmonised quality framework ensure that pharmaceutical partners receive consistently unmatched quality and reliability throughout a manufacturing project.
Key components such as uniform quality systems, regulatory compliance, successful technology transfer and organisational culture work together to build resilient drug development processes.
This allows pharmaceutical companies to deliver life-saving therapies to the patients who need them as quickly as possible while ensuring safety and effectiveness.
