This is part five of an ongoing series of posts from Mohan Ponnudurai as he attends and speaks at quality shows and conferences across the globe.
As part of UBM's series of conferences and seminars in India, the latest was on Unannounced Audits, held at the Westin Garden City in Mumbai on August 29 & 30. Sparta Systems was one of the sponsors and I was one of the presenters.
As we all know, India is one of the largest suppliers of API and other pharmaceutical products as well as biosimilars. This is a high growth segment, and an essential part of pharmaceutical and biotech products that are in the US market. Because of the patient safety and product efficacy concerns, India is one of the two countries that FDA has local representation (the other is China). FDA performs a lot of oversight audits and inspections in India. Under the mandate, FDA is allowed to perform unannounced audits in India because of their local representation status.
This conference was about what to expect during an unannounced audit, how to behave, what is expected by the auditors and what are the best practices to follow as part of ongoing activities. Even though this is centered around audits, the reality is that the audits are not living in their own silos. Audits are connected to quality activities such as investigations, root cause analysis, risk assessments, corrective/preventive actions, effectiveness etc. Auditors are continually looking for ‘evidence’ of activities and resolutions and getting these outputs in a timely manner for the auditors is critical for a successful audit.
I spoke about audits and what goes on after the audit, how a holistic quality management system (QMS) helps these companies with clear-cut processes, timeliness and gaining visibility to tasks and making proactive decisions based on insights to stay ahead of the audit based reactive measures.
Most of the attendees were from the pharma (products and API) manufacturing space and many have used TrackWise and spoke highly of its’ audit management effectiveness. It was generally an educational and informative event for all.
Stay tuned for part five of “Where in the World is Mohan Ponnudurai” coming soon.