N-nitrosamine impurities, a class of potentially carcinogenic substances, have become a significant concern in the pharmaceutical industry. These compounds can form during the drug manufacturing process or due to degradation.
As technology continues to advance, the integration of artificial intelligence (AI) into GMP environments promises enhanced efficiency, productivity, and quality control. However, alongside these benefits come unique challenges and considerations, particularly concerning regulatory compliance.
Restricted Access Barrier Systems (RABS) have emerged as a cutting-edge technology to address challenges, providing a robust solution for aseptic processing in pharmaceutical and biotechnology industries. In this article, we will delve into what RABS technologies are and explore the steps involved in their successful implementation.
Keeping health products safe means ensuring that the product lifecycle are implemented and in control. The health product lifecycle here refers to all stages in the pre- and post-market “life” of a health product. According to Health Canada, the stages may include several or all of the following: pre-clinical studies, clinical trials, submission of product
As per Health Canada Guidance on GMP, GUI-0001, Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of a drug across the product lifecycle [1]. In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks