Reshoring or onshoring pharmaceutical manufacturing processes can be a complex yet rewarding endeavor. Whether driven by geopolitical factors, supply chain challenges, or the desire to have greater control over production, it requires careful planning, clear communication, and strict adherence to regulatory standards to ensure the transition is seamless. In this blog, we will explore the key steps involved in the tech transfer process for reshoring or onshoring pharmaceuticals.
The first critical step in any tech transfer process is conducting a comprehensive risk assessment. This helps identify potential risks associated with shifting production to a new site, such as quality control issues, supply chain disruptions, and compliance with local regulations. A gap analysis should be performed to compare the capabilities of the existing site with those of the new facility, particularly focusing on equipment, process control systems, and environmental controls. This assessment ensures that the new site is well-suited for the pharmaceutical products being transferred.
Next, it is essential to document all existing processes. Clear documentation of the current manufacturing process serves as a baseline and highlights areas that may require improvement or carry risks. This documentation includes standard operating procedures (SOPs), process flow diagrams, control strategies for critical process parameters, and batch records. Having accurate, up-to-date records ensures that the tech transfer will proceed smoothly and that no vital steps are missed.
Once the existing processes are documented, it’s time to assess the capabilities of the new facility. The new site must meet the stringent requirements for Good Manufacturing Practices (GMP) and have the necessary infrastructure, equipment, and expertise to handle the production. This may involve upgrading or purchasing new equipment, ensuring that the facility can support the specific needs of the pharmaceutical products being transferred.
With the foundational work completed, the next step is to define the tech transfer plan. This detailed plan outlines the steps, timelines, resources, and responsibilities involved in transferring the process. Key personnel from both the sending and receiving sites must be identified, and the timeline for each phase of the transfer should be established. It is also critical to specify the training requirements for the receiving site’s team and establish the necessary qualification and validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Training is a significant part of the process, and it is crucial to ensure that the receiving site’s team has the proper knowledge and skills to operate the new processes. This involves hands-on training, workshops, and providing clear documentation. Training should focus on the technical aspects of the processes, equipment operation, quality control practices, and troubleshooting. The goal is to make sure that the new site’s team can operate independently and effectively after the transfer.
Once training is complete, the next step is to perform pilot runs and validation. These runs are essential to validate that the transferred processes work as intended in the new facility. During pilot runs, the team can assess consistency, quality, and regulatory compliance. Any discrepancies or adjustments can be identified and corrected before scaling up to full production. This step is crucial to ensuring that the new site can handle large-scale production without any hiccups.
As the tech transfer progresses, it’s necessary to update all regulatory documentation to reflect the new manufacturing site. This includes submitting updated facility registrations, product dossiers, and batch records to regulatory authorities such as the FDA or EMA. Keeping regulatory filings current is essential for maintaining compliance and avoiding delays in product approvals or shipments.
Even after the transfer is complete, ongoing monitoring is required. The new site must maintain consistent product quality and comply with all regulatory standards. A continuous monitoring program should be implemented to track production metrics, conduct regular audits and inspections, and optimize processes based on real-time data. This ongoing oversight ensures that the new site remains in good standing and continuously improves its operations.
Finally, once the transfer process is fully established, a final knowledge transfer occurs. This step ensures that the receiving site takes full ownership of the processes. The sending site may provide continued support during the initial period after the transfer to ensure smooth operations. Over time, the receiving site assumes complete responsibility for the process and its continuous improvement.
Reshoring or onshoring pharmaceutical processes is a challenging yet essential part of modern manufacturing. By following a structured, thorough tech transfer process, companies can ensure a smooth transition, minimize risks, and maintain product quality. As the pharmaceutical industry continues to evolve, tech transfer will play an increasingly important role in building resilient and efficient supply chains.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
