Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
Menu
Zamann Pharma Support GmbH offers services to pharmaceutical companies, providing hands-on assistance in the execution of Cleaning Validation activities. Our expert consultants work closely with clients to execute the Cleaning Validation tasks
Our experts can support the development of robust protocols, created to their specific processes and products. This includes conducting risk assessments to identify critical process parameters and defining sampling plans to ensure representative data collection. We execute Validation Protocols studies, providing guidance on protocol implementation and ensuring adherence to established procedures and regulatory standards.
We support companies in the systematic collection of validation data, including process parameters, product characteristics, and performance indicators. Our experts employ statistical analysis techniques to evaluate the collected data, assess process variability, and determine the robustness of the manufacturing process. By analyzing validation data comprehensively, we identify trends, deviations, and potential areas for process improvement.
Our team assists in the preparation of comprehensive Validation Reports that document the entire process, from protocol development to data analysis and conclusions. We ensure that validation reports are clear, concise, and compliant with regulatory requirements, including FDA and EMA guidelines. Our reports provide a detailed overview of the validation activities performed, the results obtained, and the conclusions drawn, facilitating regulatory submissions and audits.
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
