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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Water Systems Validation (WFI, PW and Pure Steam) – Strategy Definition

Zamann Pharma Support offers consultancy services aimed at crafting comprehensive background documentation, such as necessary SOPs, to guide clients in executing Water Systems Validation. Through meticulous planning and documentation, we ensure that clients have the necessary framework to perform validation activities for Water for Injection (WFI), Purified Water (PW), and Pure Steam systems.

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SOP Development

Our team collaborates with clients to understand their specific water systems and validation requirements, ensuring that the developed SOPs are tailored to their unique needs.

We outline each step of the validation process in the SOPs, including system qualification, performance qualification, and ongoing monitoring procedures. Emphasizing clarity and comprehensiveness, our SOPs incorporate best practices and regulatory guidelines to facilitate smooth execution and compliance with industry standards.

Risk Assessment

Zamann Pharma Support conducts risk assessments to evaluate potential hazards and vulnerabilities in the water systems validation process. We assess various factors such as system design, operational procedures, maintenance protocols, and environmental conditions to identify critical control points and potential sources of contamination. Through rigorous risk analysis, we develop mitigation strategies and control measures to minimize risks and ensure the integrity and purity of water systems throughout the validation process.

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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