Supply chain essentials for GMP cell culture products

In this interview with RegMedNet, our experts Alica Tegethoff (AT), Project Engineer in Media Production, and Elena Cava Exposito (ECE), Material Supply Manager give their insights into the essential supply chain requirements that adhere to Good Manufacturing Practice (GMP) for cell culture products. Together, they discuss the importance of implementing a qualified supply chain for GMP cell culture products, the associated risks that may comprise critical points in the supply chain and best practices needed to maintain GMP standards in cell culture products. 

Alica Tegethoff (AT): A qualified supply chain is essential for GMP cell culture products as it ensures consistent quality, efficacy and safety of the final product. Many aspects, like using high-quality raw materials, providing comprehensive documentation, meeting regulatory standards and guaranteeing traceability in all process steps, are part of a qualified supply chain. By adhering to this and many other criteria, a robust overall process is created from the procurement of raw materials through GMP-compliant production to the delivery of the final product. In conclusion, a qualified supply chain is not just the best practice but a necessity for GMP cell culture products.

AT: In today’s global supply chains, several key GMP-related risks are critical. The following three examples illustrate the complexity of critical points in the supply chain. 

• Regulatory Compliance
  All partners and processes involved in the production and distribution of the final product must follow stringent GMP regulatory requirements. Process errors and deviations can result in severe consequences, including regulatory actions or product recalls. Also, inadequate documentation can create compliance problems.
• Quality Control 
  Inadequate Quality Control procedures during manufacturing and testing can result in incorrect products, recalls and regulatory actions. This applies to both raw materials and final products.
• Supply Chain Disruptions 
  Natural disasters, pandemics and geopolitical instability can lead to delivery delays. This can have a negative impact on production schedules and result in supply shortages when critical products with stringent specifications cannot be obtained from alternative suppliers

By proactively addressing different risks through robust risk management strategies, companies can improve their supply chain resilience and ensure the safety of their products.

Alica Tegethoff

Project Engineer in Media Production at PromoCell

Elena Cava Exposito (ECE): To maintain GMP compliance, changes in raw material specifications or suppliers must be managed through a formal change control process. This begins with submitting a documented change request that describes the proposed change and its justification. A risk assessment should follow, evaluating how the change might affect product performance, manufacturing processes, or regulatory compliance. If the change involves a change in raw material or supplier, a sample should be ordered and tested for functionality in the final product, including comparative analysis and, if necessary, stability studies. The change must be reviewed and approved by a competent authority like Quality Assurance or Regulatory Affairs Department. All related documentation, such as specifications, manufacturing protocols or qualified supplier lists, should be updated accordingly. The effectiveness of the change should be tracked through defined quality indicators and periodic supplier evaluations.

Elena Cava Exposito

Material Supply Manager at PromoCell

ECE: To ensure traceability throughout the supply chain, GMP-compliant operations must implement rigorous documentation practices. Comprehensive batch manufacturing records should be maintained to capture every step of production and packaging, including raw material lot numbers, equipment used, personnel involved and process parameters. Quality control data, including functional test results and deviation reports, must be recorded and linked to specific lot numbers.

Material traceability must be supported by clearly defined material specifications for each raw material and Certificates of Analysis, along with detailed records of supplier information, lot numbers and receipt dates. Inventory and warehouse logs should document material movements, storage conditions, expiry dates and the status of materials such as quarantined, released, or rejected. 

As mentioned before, any changes to processes, suppliers, or materials must be documented through a change control system, including risk assessments and necessary approvals. Deviations, out-of-specifications (OOS), and associated Corrective and Preventive Actions (CAPA) must be recorded, with root cause analyses and follow-up actions clearly documented. Finally, supplier qualification and audit records should be maintained, including audit outcomes and signed quality assurance agreements, to ensure ongoing compliance and accountability across the supply chain.

AT: The future of GMP in supply chain management under the influence of digitalization will be characterized by increased automation, data-driven decision making, improved compliance and enhanced transparency and traceability. This will lead to greater efficiency and more interconnected and integrated supply chains. The application possibilities are virtually limitless, from real-time tracking of goods to automated quality-check, or improved risk management.

The integration of AI has the potential to maximize productivity and minimize costs by, e.g., monitoring product quality, balancing inventory levels, identifying fuel-efficient delivery routes, analyzing supplier performance metrics, or reducing risks of non-compliance However, there will also be some challenges such as  maintaining data security, implementing complex digital technologies and training/education of employees in the fields of AI usage.

All in all, digitalization and use of AI bring a big potential to create more flexible, resilient and responsive supply chains that meet the demands of a rapidly changing marketplace.

This interview was made in collaboration with RegMedNet.