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At Zamann Pharma Support GmbH, we provide expert consultancy services focused on developing a robust water validation system strategy for pharmaceutical operations. Our services center around crafting comprehensive background documentation, including SOPs and guidance documents, to support clients in planning and executing Water Systems Validation activities for Water for Injection (WFI), Purified Water (PW), and Pure Steam systems. By integrating regulatory guidelines from FDA, EMA, and pharmacopeial references, we ensure that clients have a solid framework to perform validation activities successfully. Our systematic approach promotes regulatory compliance, operational consistency, and long-term system integrity.
As part of our water validation system services, Zamann Pharma Support GmbH collaborates closely with clients to develop customized Standard Operating Procedures (SOPs) tailored to their specific water systems and operational requirements. Each SOP outlines every critical step of the validation process, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), sampling strategies, and continuous monitoring practices. Emphasizing clarity, completeness, and regulatory compliance, our SOPs incorporate current best practices and industry standards. This ensures that water system validation activities are well-organized, repeatable, and traceable, supporting audit readiness and long-term maintenance of water quality standards.
Risk management is an essential component of any successful water validation system, and Zamann Pharma Support GmbH specializes in performing detailed risk assessments as part of our service offering. We evaluate potential hazards linked to system design, operational practices, maintenance routines, microbial contamination risks, and environmental influences. By identifying critical control points and system vulnerabilities early, we develop mitigation strategies that are integrated directly into the validation process. Our rigorous risk analysis ensures that water systems maintain integrity, reliability, and regulatory compliance throughout their lifecycle, safeguarding the purity of WFI, PW, and Pure Steam used in pharmaceutical manufacturing.
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
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
