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 strategic consultancy for Batch Record Review, assisting pharmaceutical companies in establishing an effective framework for the compliant execution of the activity. We provide guidance on creating essential Standard Operating Procedures (SOPs) or evaluate existing processes, to identify areas for enhancement.
Our team conducts thorough evaluations of existing Batch Record review processes. Through detailed analysis, we identify strengths, weaknesses, and areas for improvement, considering factors like data integrity, completeness, accuracy, and regulatory compliance. Recommendations are then provided to enhance process efficiency and effectiveness.
Zamann Pharma Support collaborates closely with clients to craft comprehensive and customized Standard Operating Procedures (SOPs), describing clear procedures, responsibilities, review criteria, documentation requirements, and escalation processes, ensuring consistency and alignment with regulatory requirements.
We offer training sessions and implementation support to the necessary teams involved in batch record review. These sessions cover essential topics such as review protocols, data interpretation, error identification, and regulatory compliance. Ongoing support is provided to address challenges and ensure successful implementation of optimized review processes.
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.
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.
