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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Process Validation – Execution

Zamann Pharma Support offers consultancy services, specializing in conducting thorough assessments to evaluate the current state of Process Validation within client organizations. Our focus is on identifying potential GAPs in the existing practices and assessing their compliance with international standards (e.g.: FDA and EMA)

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Document Creation

Our team develops robust validation protocols, risk assessment documents, and comprehensive reports customized according to the specific processes and requirements.

We ensure that all documentation aligns with regulatory guidelines and industry best practices, providing a solid foundation for the validation process.

Process Oversight

Zamann Pharma Support provides guidance and support to clients throughout the execution of process validation activities, ensuring adherence to established protocols and procedures.

We work closely with client teams to monitor and oversee validation activities, addressing any issues or deviations that may arise during the process.

Reporting and Documentation

We compile and organize all validation data and results, facilitating the preparation of detailed reports documenting the validation process and outcomes. Our team ensures that all documentation is accurate, complete, and compliant with regulatory requirements, providing clients with the necessary documentation for regulatory submissions and audits.

Customized support for Qualification and Validation

We provide Qualification and Validation support, designed specifically to your facility and products, ensuring that each process is meticulously designed, documented, and verified. With our hands-on support, you can trust that your operations meet all regulatory standards

Why Zamann?

Zamann’s expertise in Qualification and Validation is rooted in industry best practices and rigorous global regulatory insight. Our team brings a thorough approach that secures compliance, improves reliability, and supports your facility’s operational success

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