In the highly regulated biopharmaceutical and CGT manufacturing industry, audit and inspection readiness play a vital role in ensuring compliance with strict quality standards. Every year, the FDA conducts thousands of inspections in the biopharmaceutical and CGT manufacturing industry, making audit readiness a paramount concern for companies in this sector. Through a proactive approach and the adoption of specific practices, manufacturing organizations can ensure seamless audits, comply with regulations, and demonstrate their commitment to maintaining high-quality standards at all times.
In my recent article in Pharmaceutical Online, I discuss six practices every organization should employ and emphasizes the significance of collaborative efforts between manufacturing and quality teams to foster a culture of continuous improvement. By implementing these six effective strategies such as clear communication channels, robust document control, effective training programs, and real-time monitoring, companies can proactively prepare for audits and inspections. At Quality Executive Partners, we have been working for years to support clients in preparing for audits and inspections, and helping establish a lasting approach to being successful and getting products to market.
Sarah Boynton, a Consultant on the Quality Executive Partners team, has extensive experience in the biopharmaceutical/cell and gene therapy space, with a particular focus on cGMP training, human performance/error prevention, downstream processing, and non-conformance investigations. Prior to joining QxP, Sarah worked for Catalent Pharma Solutions, KBI Biopharma, AstraZeneca, MedImmune, and GlaxoSmithKline.
Check out Sarah’s recent blog: “The 5 Questions You Need to Ask After a Human Error Event Occurs.”