Revision and Harmonization of Quality and Technical Agreements

A German pharmaceutical company approached Zamann requesting support as they needed technical and operational consultancy to ensure that their current technical and third-party quality agreements (TA and QTA) are reviewed and renewed. Therefore, we proposed a complete documentation update, considering German and European approaches, pharmacovigilance inclusion and global company harmonized approaches to ensure compliance with regulations and company guidelines. We offered a fast, robust and harmonized documentation renewal.

Challenges Faced

Regulatory Scrutiny: The client’s technical agreements were subject of upcoming German health authority inspection, and any outdated TA documentation could result in findings or penalties. Austrian, Switzerland and Nordics upcoming authority inspections were also considered.
Document Volume: The technical documentation was extensive, including multiple third parties on local country and European regional country level, including multiple company entities.
Complexity of Regulations: EU GMP and GDP requirements are extensive and complex, requiring a deep understanding of risk-based approaches and lifecycle principles. In addition, it is important to consider the business aspects and to ensure business continuity.
Time Sensitivity: The TA needed to be completed within a short time frame to meet internal and external deadlines.

Zamann Pharma Support’s Approach

Project Initialization: Conducted an initial kick-off meeting with all relevant stakeholders, to understand goals, timelines, and specific concerns. Review of the current technical agreement’s documentation and third parties list to map the documentation effort.
Document Review: Each TA was reviewed against global company harmonized documentation and current agreements. Key focus on the documents distinguished between manufacturing, distribution, warehousing, repackaging, laboratory services. Traceability matrices, and Change Control records were created for this purpose.
Key Topics Evaluated: The former TA documentation emphasis on risk-based approaches. The renewed documentation, including pharmacovigilance and more detailed responsibility matrices. Followed audits were planned to evaluated for consistency and completeness with necessary requirements of the third parties.
Support for Implementation: Provided updated templates with local requirements, manuals and list to guide routinely document revisions. Conducted workshops with the client’s team and internal QA to ensure a clear understanding and harmonization of execution. Establishment of a follow-up system to fast process with audits based on TA requirements.

Results Achieved

Regulatory Compliance: The TA renewal brought the client’s documentation in line with German health authority requirements and passed with no comment during the inspection.
Improved Documentation: The client’s documentation was streamlined and harmonized, making it easier to manage, review, and present during inspections.
Risk Mitigation: Identifying and addressing critical GAPs reduced the risk of regulatory findings or penalties.
Team Empowerment: By involving the client’s team in workshops and CAPA planning, they gained a deeper understanding of validation best practices and regulatory expectations.
Timely Completion: The assessment and remediation plan were completed on schedule, ensuring the client could meet their internal deadlines.

Client Testimonial

“Zamann Pharma provided exceptional support in harmonizing our technical and quality agreements. Their expertise ensured our documentation met German and EU regulatory requirements, enabling us to pass inspection without any comments.

Their clear guidance, tailored templates, and workshops empowered our team to maintain compliance independently. The project was completed on time, exceeding our expectations. We highly recommend Zamann Pharma for their professionalism and efficiency.”

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