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At Zamann Pharma Support GmbH, we offer specialized support for the execution of water system validation activities, covering Water for Injection (WFI), Purified Water (PW), and Pure Steam systems. Our expert team provides hands-on assistance in planning, protocol creation, execution, sampling, and documentation to ensure full regulatory compliance and operational efficiency. Water system validation is crucial to guarantee the safety, purity, and consistent quality of pharmaceutical water systems. Our structured approach ensures that your water treatment, storage, and distribution systems meet stringent pharmacopeial and regulatory standards, ensuring reliability, audit readiness, and long-term manufacturing excellence.
Proper sampling execution is fundamental to effective water system validation, and our experienced team ensures that every sampling activity meets the highest standards. We conduct representative sampling at critical points within water systems, including sampling points, distribution loops, storage tanks, points of use, and purification units. Each sample is collected in strict adherence to predefined protocols and regulatory requirements, using validated sampling techniques and secure handling methods. Our experts document all activities thoroughly to maintain traceability, integrity, and compliance. This rigorous sampling execution process is designed to provide accurate, meaningful results that underpin the success of your water system validation efforts.
Our support extends through the full execution of water system validation protocols, ensuring that all activities align precisely with regulatory and operational expectations. We provide guidance and oversight from the earliest stages, covering Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of water generation and distribution systems. Our team ensures that all protocol steps are conducted correctly, acceptance criteria are strictly applied, and results are properly documented. With expert oversight at every phase, your water system validation processes are streamlined, controlled, and positioned for successful regulatory review and long-term operational sustainability.
Comprehensive and compliant documentation is a cornerstone of water system validation, and Zamann Pharma Support GmbH ensures every detail is accurately captured. Our team assists in creating and managing critical documents, including Validation Master Plans (VMPs), validation protocols, sampling records, and detailed validation reports. We ensure all documentation complies with pharmacopeial monographs and international regulatory guidelines. Additionally, we prepare summary reports that outline validation activities, findings, deviations, and corrective actions taken. This complete documentation package supports audits, inspections, and regulatory submissions, providing full traceability and demonstrating a robust and compliant water system validation process.
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
