FDA inspections recommence on February 7, 2022. Are you ready? Sanjay Shetgar from NSF International has created a useful guide to help you prepare.
The FDA has restarted unannounced inspections of manufacturing facilities. The restart commenced on February 7. Inspections were halted in March 2020 with the outbreak of COVID-19. A limited number of inspections had restarted; however, they were again paused due to the emergence of the Omicron variant in December 2021. The agency plans to proceed with planned inspections in countries that have received country clearance and fall under the Centers for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendations. India and China belong to these categories. The FDA plans to restart additional foreign surveillance inspections in April.
Companies need to be ready for the restart of FDA inspections. NSF International’s global team of pharmaceutical and biotech experts is already assisting companies with their preparations.
You can speak with one of our experts by completing the “Ready to Begin the Process” form below and ensure that your company is ready when the inspectors call.
We have created a brief essential guide to the issues you need to be aware of as FDA inspections return.
Webinar: “GMP Remediation & Compliance: What You Need to Know in 2022”
Join NSF International expert John Johnson on March 2 at 2 p.m. GMT for a 30-minute look at how you and your company can best prepare for 2022. John will cover questions including:
• What are the likely hot topics that will keep you up at night?
• What will you want to prioritize so that your staff, your subject matter experts and your departmental leaders are working on the right things at the right time for the right reasons?
LINK: Book your space for the webinar by clicking here.
White Paper: “Quality Systems Remediation 101”
NSF International expert Maxine Fritz, a former FDA investigator, has created a helpful tool for those seeking to assist companies embarking on remediation projects. She suggests a three-Cs approach: company culture, communication and collaboration.
Read “Quality Systems Remediation 101” here.
Case Study: What Happens When a License Is Suspended?
The impact of a suspension of manufacturing activities at a site can be catastrophic. Lynne Byers, Global Managing Director, Pharmaceuticals and Dietary Supplements Consulting, at NSF International, looks at how a suspension affected a company in the UK. She also explores the steps NSF took to assist the company and to get them back to manufacturing and distribution. Lynne Byers was formerly Head of Inspectorate and Licensing at the UK’s MHRA.
Training: Pharmaceutical Quality Systems
The quality of your products depends on the quality of your people and the effectiveness of your pharmaceutical quality system. Our global team of experts can deliver in-person and online training to companies in the pharmaceutical sector. They can also provide customized training specific to your needs.
Find out more about pharmaceutical quality systems training here.
Talk to Us Today
We can assist your company with any issues relating to remediation, inspection readiness and GMP compliance. Email: healthsciences@nsf.org or click here to contact us: https://www.nsf.org/news/fda-inspections-recommence
Sanjay Shetgar is Vice President of Pharmaceutical Services with NSF International. He has over 30 years of pharmaceutical management experience in both plant operations and corporate offices, working with Cipla, Dr.Reddy’s and Wockhardt in India. He has held senior positions as Vice President, Head Global Corporate Quality and Senior Vice President, Head Operations Quality with Dr.Reddy’s and Wockhardt. His experience includes API & Intermediates, various Drug Product forms including Biologics.
