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, dedicated to conducting comprehensive assessments of clients’ Cleaning Validation processes. Our focus is on evaluating the existing procedures and executed validations, to identify any GAPs or deficiencies in compliance with international standards set by regulatory bodies like the FDA and EMA. Through rigorous GAP assessments, we provide clients with valuable insights and recommendations to enhance their cleaning validation practices and ensure regulatory compliance.
We meticulously review clients’ existing cleaning validation documentation, including SOPs, protocols, reports, and risk assessments, to assess their alignment with regulatory requirements.
Our team identifies any discrepancies, inconsistencies, or deficiencies in the documentation, highlighting areas for improvement and corrective actions.
Zamann conducts thorough evaluations of clients’ cleaning validation processes, examining key steps such as cleaning procedures, worst-case scenario identification, sampling methods, and acceptance criteria.
We assess the effectiveness and robustness of the processes in place, identifying any weaknesses or gaps that may impact the quality and safety of pharmaceutical products.
Our consultants perform a comprehensive GAP analysis to compare clients’ cleaning validation practices against applicable regulatory standards and guidelines.
We identify areas of non-compliance or potential risks and provide detailed recommendations for remediation, prioritizing actions to address critical gaps and ensure regulatory adherence
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
