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At Zamann Pharma Support GmbH, we provide comprehensive support for executing water system validation activities, covering Water for Injection (WFI), Purified Water (PW), and Pure Steam systems. Our team assists clients throughout the entire validation lifecycle, from planning and protocol development to sampling, risk assessment, and final reporting. We ensure that every validation phase meets stringent regulatory requirements and aligns with industry best practices. By offering hands-on expertise, systematic oversight, and detailed guidance, we help pharmaceutical companies validate their water systems effectively, ensuring operational reliability, product safety, and full compliance with FDA, EMA, and international standards.
Developing robust and compliant protocols is a critical foundation for successful water system validation, and Zamann Pharma Support specializes in delivering precisely tailored solutions. We collaborate closely with clients to develop customized protocols specific to their water systems, covering WFI, PW, and Pure Steam units. Each protocol clearly defines procedures, acceptance criteria, sampling points, test parameters, and verification methods necessary for comprehensive system validation. By ensuring that all elements are meticulously planned and documented, we create a solid groundwork that facilitates smooth execution, regulatory alignment, and traceable validation outcomes that meet international compliance expectations confidently.
Comprehensive risk assessment is a core element of our water system validation strategy, ensuring that potential vulnerabilities are identified and addressed proactively. Zamann Pharma Support conducts systematic evaluations of water system designs, operational practices, maintenance routines, and microbial control measures. We prioritize critical risks that could impact water quality, system integrity, or regulatory compliance, and integrate effective mitigation strategies into the validation plan. By embedding risk assessment into the entire validation lifecycle, we enhance the reliability, safety, and efficiency of water systems, minimizing the likelihood of contamination events or compliance deviations during manufacturing operations.
Our team provides end-to-end management of the water system validation execution process, ensuring strict adherence to established protocols and regulatory requirements. We supervise activities such as system sampling, microbial and chemical testing, performance evaluations, and deviation management. Throughout the execution phase, we maintain detailed records and observations to ensure traceability and data integrity. Upon completion of validation testing, we prepare comprehensive validation reports that summarize findings, identify observations, highlight corrective actions if necessary, and present final conclusions. This detailed reporting framework supports regulatory submissions, inspections, and audit-readiness, ensuring full transparency and sustained compliance for clients.
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
