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At Zamann Pharma Support GmbH, we offer specialized consultancy services focusing on conducting structured water system validation gap assessments. Our goal is to evaluate the existing water system validation activities, scrutinize implemented SOPs, and review executed validations to ensure alignment with international regulatory standards, including FDA and EMA guidelines. Through meticulous gap analysis, we identify deficiencies, inconsistencies, or compliance risks within the validation framework. By providing clear, actionable recommendations, we enable clients to enhance compliance, strengthen validation practices, and mitigate regulatory risks effectively, ensuring that their Water for Injection (WFI), Purified Water (PW), and Pure Steam systems remain inspection-ready.
As part of our water system validation gap assessment services, Zamann Pharma Support GmbH conducts a thorough review of client SOPs related to water system operations and validation. Our experts assess documents governing system installation, operational procedures, maintenance schedules, cleaning practices, and performance qualifications. Each SOP is evaluated for completeness, accuracy, and regulatory compliance against FDA, EMA, and pharmacopeial standards. We identify any procedural gaps, inconsistencies, or outdated practices that could impact validation effectiveness. Our detailed review provides clients with actionable insights and practical recommendations to enhance their procedural controls and maintain robust regulatory compliance frameworks.
Another critical component of our water system validation gap assessment involves evaluating the validation documentation supporting WFI, PW, and Pure Steam systems. Zamann Pharma Support GmbH reviews validation protocols, executed test reports, sampling results, and supporting records for completeness, traceability, and alignment with regulatory requirements. We verify whether validation studies adequately address critical parameters such as microbial control, chemical attributes, flow rates, and operational performance. Through careful documentation analysis, we identify deviations, inconsistencies, and compliance risks, providing clients with targeted recommendations to improve documentation integrity, enhance regulatory readiness, and strengthen validation lifecycle management practices.
To conclude the water system validation gap assessment, Zamann Pharma Support GmbH performs a comprehensive compliance gap analysis, benchmarking client practices against international regulatory expectations. Our experts use structured methodologies to compare SOPs, validation execution records, and monitoring programs against FDA, EMA, and ISPE standards. We prioritize identified gaps based on risk severity, potential product impact, and regulatory scrutiny probability. By delivering detailed corrective action plans and strategic roadmaps, we enable clients to address compliance challenges systematically, elevate operational quality, and ensure that their water systems validation activities remain aligned with evolving regulatory expectations and inspection requirements.
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
