Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer consultancy services focusing on crafting essential background documentation required for Process Validation initiatives. We meticulously develop the necessary SOPs, customized to clients’ specific needs and regulatory standards. By providing comprehensive documentation, we ensure clients have a solid foundation to guide the execution of Process Validation activities efficiently and in compliance with industry regulations.
Our team conducts in-depth discussions with clients to understand their specific Process Validation needs, requirements, and objectives.
We analyze existing processes, systems, and regulatory guidelines to create the SOPs to the unique context of each client’s operations.
Zamann Pharma Support meticulously develops SOPs for Process Validation, covering all relevant aspects such as validation planning, protocol development, execution, and reporting.
We customize SOPs to align with clients’ internal procedures, organizational structure, and regulatory requirements, ensuring clarity, comprehensiveness, and compliance.
Prior to finalization, our team conducts thorough reviews of the drafted SOPs to ensure accuracy, consistency, and compliance with regulatory standards.
We collaborate closely with clients to validate the SOPs through pilot testing and feedback collection, refining them as needed to address any GAPs or issues identified during the review 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
