Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
Menu
We offer support for execution of Validation activities regarding Water Systems (WFI, PW, and Pure Steam), ensuring efficient and compliant outcomes. Our experts provide hands-on assistance in creation and execution of validation protocols, conducting sampling, and generating necessary documentation to meet regulatory requirements
Our team conducts sampling of water systems at critical points to ensure representative sampling. This includes sampling points, points of use, distribution loops, storage tanks, and purification systems. All samples are conducted according to established protocols and regulatory requirements, with careful attention to sampling techniques, sample handling, and documentation of results.
We provide guidance and oversight throughout the execution of validation protocols for water systems, ensuring that activities are performed correctly and in accordance with predefined acceptance criteria. Our team assists since the initial steps. including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of water treatment and distribution systems.
We support the creation and management of validation documentation, including Validation Master Plans (VMPs), protocols, and reports. Our team ensures that documentation is comprehensive, accurate, and compliant with regulatory requirements such as those outlined in pharmacopeial monographs and guidelines. We assist in the preparation of summary reports summarizing validation results, deviations encountered, and corrective actions taken, providing a comprehensive record of the validation process for regulatory review.
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
