To ensure compliance and uphold product quality, pharmaceutical companies must stay updated on the latest trends and regulations. A crucial aspect of this is familiarizing themselves with the key inspection findings from regulatory bodies like the MHRA (Medicines and Healthcare products Regulatory Agency). The MHRA's 2019 report highlighted the most frequently cited deficiencies in Good Manufacturing Practice (GMP) inspections, organized according to relevant chapters and annexes. These findings encompass various areas including the pharmaceutical quality system, documentation practices, production processes, qualification and validation procedures, premises and equipment maintenance, manufacturing of sterile medicinal products, handling complaints and product recalls, quality control measures, computerized systems, and outsourced activities. By addressing these findings, pharmaceutical companies can strengthen their compliance efforts, mitigate risks, and uphold their reputation as providers of high-quality pharmaceutical products. It is crucial for companies to proactively identify areas for improvement and implement appropriate measures to rectify these findings. This ensures that their products meet regulatory requirements and continue to be perceived as trustworthy within the industry.
As the pharma industry continues to evolve, it is important for companies to stay updated on the latest trends and regulations in order to ensure compliance and maintain a high level of quality in their products. One key aspect of this is understanding the top inspection findings from regulatory bodies such as the MHRA. In 2019, the MHRA released their annual report detailing the top 10 most-cited GMP inspection deficiencies by Annex/Chapter. In this article, we will take a closer look at these findings and provide insights on how companies can improve their compliance with these regulations.
References by Chapter & Annex – MHRA Report 2019