Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We specialize in offering the necessary expertise to create the landscape for Water Systems Validation, including the development of essential SOPs or support in evaluating existing processes for improvement. Our focus is on providing strategic orientations to enable companies to initiate or enhance their water systems validation activities effectively.
Comprehensive risk assessments and GAP analyses of existing processes, to identify areas for improvement and ensure compliance with regulatory requirements. This includes evaluating system design, operational procedures, and maintenance practices to mitigate risks and enhance system performance.
We collaborate with companies to develop SOPs outlining the procedures and protocols for Water Systems Validation activities. These SOPs include guidance on system qualification, routine monitoring, and deviation management, ensuring consistency and compliance with regulatory standards.
Additionally, our team assists in the development of validation protocols customized to the specific requirements of water systems. This includes defining validation parameters, acceptance criteria, and sampling plans to ensure the thorough and effective validation of water systems for pharmaceutical use.
We offer customized training sessions and workshops to enhance the skills and knowledge of personnel involved in Process Validation activities. These training programs cover topics such as Process Validation principles, risk assessment methodologies, and regulatory requirements, empowering staff to execute process validation tasks effectively and ensuring compliance with industry standards.
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
