Batch Record Review – Execution
Zamann Pharma Support offers specialized consultancy, providing assistance to clients overwhelmed by large volumes of Batch Records. We follow internal procedures and regulatory guidelines to meticulously review the necessary documentation, ensuring compliance and facilitating batch release. Our services aim to streamline the review process, alleviate client burden, and maintain product Quality and regulatory adherence.
Documentation Review and Analysis
Our team conducts thorough reviews of batch records, verifying data accuracy, completeness, and compliance with regulatory standards.
We analyze critical documentation, including production records, test results, and deviation reports, to ensure adherence to internal procedures and regulatory requirements.
Compliance Verification and Approval
Zamann verifies that batch records meet all internal and regulatory requirements, including those stipulated by FDA and EMA guidelines.
Upon completion of the review process and satisfaction of regulatory criteria, we provide approval for batch release, enabling clients to proceed with product distribution while maintaining compliance with regulatory standards.
Customized support for Quality Management Systems
Our team collaborates closely with you to create, maintain and improve your Quality Management Systems ensuring a perfect fit between processes and goals. From initial setup to ongoing support, we ensure that every element supports robust holistic compliance, efficiency, and long-term growth.
Why Zamann?
Zamann is committed to building Quality Management Systems that exceed expectations. With a deep understanding of regulatory requirements and global practical expertise, we ensure not only compliance with regulations, but also optimization of QMS´s workflows and continuous improvement.
