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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

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • 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Scrutiny: The client’s technical agreements were subject of upcoming German health authority inspection, and any outdated TA documentation could result in findings or penalties.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.
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Pharmaceutical team managing GMP Quality Management System (QMS) activities, reviewing change control records, CAPA documentation, deviation reports, and audit readiness data in a regulated manufacturing environment.
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Quality Management System

We work with pharmaceutical teams to design, implement, and run effective Quality Management Systems, covering change control, CAPA, deviations, and audits to support consistent GMP compliance.

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FAQ

1. What risks do outdated technical and quality agreements create during a GMP inspection?

Outdated agreements increase compliance risk because inspectors may find missing responsibilities, unclear interfaces, or non-aligned procedures. As a result, companies face potential GMP observations, delays, or even regulatory warnings. Therefore, keeping TA and QTA documents current directly reduces inspection findings and protects business continuity.

 

2. Why is a GAP analysis essential before renewing technical agreements with third parties?

A GAP analysis identifies missing controls, unclear responsibilities, and weak documentation links across suppliers and service providers. In addition, it highlights deviations from EU GMP and GDP expectations early. This allows companies to fix critical issues before authorities review the documents, which significantly improves inspection readiness.

 

3. How does harmonizing quality agreements improve compliance across multiple countries?

Harmonization aligns documentation across regions such as the EU, Switzerland, and Nordic markets. Consequently, companies avoid inconsistencies between local and global requirements. This approach simplifies audits, strengthens traceability, and ensures all third-party responsibilities follow a unified compliance framework during regulatory inspections.