Regulatory Challenges in the CIS and Russia - TOPRA In CEE WebinarNovember 22, 2023
Digital Technologies in Pharma Significantly Reduce the Risk of Cross-Contamination
According to Bloomberg, pharmaceutical contamination is one of the technical factors, that can dramatically affect a company`s financial health. “Such risks can be substantially reduced through the digital transformation of manufacturing processes,” noted Konstantin Koshechkin, Head of eSolutions Department at Inpharmatis.
Cross-contamination is the contamination of a material or product in the manufacturing process with another pharmaceutical product. Experts agree that only a clear and carefully controlled sequence of processes in strict accordance with all regulatory requirements can eliminate the risk of foreign substances entering the final product.
According to Konstantin Koshechkin, “the risk of cross-contamination imposes increased requirements, first of all, on personnel training, source of raw materials, and compliance with prescribed procedures. To manage these processes manually not only you require many different resources from manufacturers, but you cannot completely prevent human error.”
According to Konstantin Koshechkin, the use of digital technologies minimizes the cross-contamination rate.
“Currently, the pharmaceutical industry is actively introducing electronic solutions for quality management, such as eQMS Dot Compliance. In particular, the eBR and LIMS modules allow controlling all stages of pharmaceutical production. Streamlining processes are the most effective way to avoid cross-contamination. Namely, employees who are not trained to operate the equipment and who are not fully aware of how to clean it properly, will not be allowed to perform operations. The sequence of technological operations is recorded in the information system and strictly controlled with no backdating allowed. And all probable contaminations are identified, verified, and documented in the laboratory information system,” notes Konstantin Koshechkin.
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