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An employee in a controlled production environment carries cardboard boxes containing packaged products. The image illustrates export clearance, quality assurance, and logistics processes prior to distribution.
Confidential client

QP certification for the rapid export release of products from Phase 1 biotechnological clinical trials

A Client/Sponsor approached MIAS Pharma to obtain a QP certificate for the urgent export release of Phase 1 clinical trial products. This is because the client’s clinical team had enrolled patients for dosing. Additionally, the CDMO warehouse was running out of space, necessitating prompt shipment of the products, further emphasising the need for an expedited export release.

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Key challenges

  1. 1.

    Timely Project Delivery:

    Meeting the client’s urgent timeline.

  2. 2.

    Client Onboarding Process:

    Mapping the supply chain and identifying any gaps. And conducting a comprehensive risk assessment to identify and mitigate residual risks associated with the export release.

  3. 3.

    QP Familiarisation:

    Rapid understanding of the complex process within a short timeframe.

  4. 4.

    Site Compliance Status:

    The audit reports of all sites within the supply chain were reviewed to confirm each site’s compliance status.

  5. 5.

    Client/Sponsor QTAs:

    Aligning with CDMOs and their contract labs.

  6. 6.

    Regulatory Approvals:

    Ensure necessary approvals are in place to support batch release.

  7. 7.

    Batch records review:

    Reviewing and verifying the drug substance and drug product manufacturing batch records and testing results as per specification. Additionally, review of associated deviations, change controls, and Out Of Specifications (OOSs) as applicable.

How MIAS overcame the challenges

  1. Project Delivery Charter: Developed a detailed project delivery charter outlining the timeline and assigned tasks to each team member.
  2. Engagement: MIAS QP and QA teams maintained daily updates and scheduled meetings with the Client/Sponsor QA and technical teams.
  3. Parallel Processes: Completed QP familiarisation, client onboarding, risk assessment, supply chain mapping, Sponsor and CDMO QTA reviews, and audit reports review for all sites on the supply chain concurrently.
  4. Document Review: MIAS QP and QA teams reviewed batch manufacturing records to ensure GMP compliance and regulatory requirements for both local and export releases. Any document gaps were communicated promptly to the client for resolution.
  5. Collaborative Effort: MIAS QP and QA teams worked closely with the Sponsor/Client and CDMO throughout the process.
  6. Supply Chain Support: Ensured full support within the supply chain to release the clinical trial batch on time.

Issues Encountered

  • MIAS QP certified the batch and issued a certificate to CDMO. However, the stock was still at the CDMO site and not shipped to the Client/Sponsor site.
  • Post-certification, the CDMO identified an error in lab results and notified MAIS QP of this issue. It was confirmed that the results are still within specification, and it is report-only results.
  • Immediately MIAS QP raised deviation internally and requested CDMO QP to provide an investigation report with risk assessment.
  • MIAS QP collaborated with CDMO QP and the Sponsor to conduct an extensive investigation linked to the risk assessment.
  • MIAS QP and QA led the investigation, identifying the root cause and suggesting appropriate CAPA.
  • MIAS QP closed the deviation by providing a justification statement for its release and re-certified the batch successfully well within time.

Result

The clinical trial batch was re-certified by MIAS QP for export release on time. The client was highly satisfied with the MIAS team, praising their leadership, technical expertise, collaborative efforts, and seamless communication throughout the process. Subsequent releases were completed without issues, leading to continued exciting projects with the client.

Summary and Conclusion

MIAS successfully managed a complex and urgent project, ensuring the timely export release of Phase 1 clinical trial products through accurate planning, collaboration, and communication. The team’s ability to handle challenges and provide comprehensive support led to a positive Client/Sponsor experience and ongoing partnership.

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MIAS Pharma provides the following services:

QP Services

Clinical QP Services

Personnel and training for QP, QA & RP

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