Being non-compliant is a risk no company can afford, especially in such a highly regulated environment like Life Sciences.
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The COVID-19 pandemic has posed several challenges to the pharmaceutical industry, including FDA and EMA inspections.
The COVID-19 pandemic has had a significant impact on regulatory inspections conducted by the FDA and EMA, resulting in a backlog of inspections. While both agencies have implemented measures to mitigate the impact of the pandemic, including remote inspections, the backlog of inspections is expected to have a lasting effect on the industry.
The impasse of inspections is likely to result in delays in approval of new drug applications and new product launches. This is because the FDA and EMA require that manufacturing facilities be inspected and meet regulatory standards before they can approve a product for sale.
To address the backlog of inspections, the FDA and EMA have implemented measures such as prioritizing inspections of facilities with higher risk products and leveraging remote inspection capabilities. However, it is predictable that it will take some time for the agencies to fully catch up with the backlog.
Here are some lessons learnt from FDA and EMA inspections and audits during COVID-19:
Remote Inspections. The FDA and EMA have conducted remote inspections using video conferencing tools, where possible. This has helped to reduce the backlog of inspections and has enabled the agencies to continue monitoring the safety and efficacy of drugs and medical devices.
Mutual Recognition. In light of the pause in inspections due to COVID-19, the FDA established a policy expanding the use of the mutual recognition agreement (MRA) it has with the European Union to include inspections conducted outside of Europe by European regulators. The FDA also began using information from inspections conducted by other regulators—specifically, regulators that are among the 53 members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), such as Australia, Canada, Japan, and South Africa.
Adapting to Change. Companies have had to be flexible and adaptable during this time. They have had to implement new procedures to ensure the safety of their employees while continuing to meet regulatory requirements.
Communication. Clear and transparent communication between companies and regulatory agencies was critical during this time, such as remote working arrangements or manufacturing delays.
Virtual Audits. Companies have had to adapt to virtual audits, where inspectors review documents remotely. This has helped to ensure that audits are still conducted, despite travel restrictions and other challenges.
Remote Document Review. Companies have had to provide electronic access to their documents for remote review by regulators. This has helped to speed up the process and reduce the backlog of inspections.
What should a company do to be ready for future inspections?
It is important for companies to plan ahead and anticipate potential delays caused by the inspection backlog. This includes having contingency plans in place, and ensuring that supply chains are robust and able to recover quickly from difficult conditions. Companies should also maintain clear and transparent communication with regulatory agencies to minimize delays in the approval process.
Ensure Compliance. Companies should maintain compliance with regulatory requirements at all times. This includes adherence to current Good Manufacturing Practices (cGMP), Data Integrity requirements and other relevant regulations.
Maintain Documentation. Documentation is a critical aspect of Agencies’ inspections. Companies should ensure that all documentation is complete, accurate, and up-to-date. This includes maintaining records of manufacturing processes, quality control, and product testing in line with Good Documentation Practice expectations.
Perform Self-Inspections. Companies should perform regular self-inspections to identify and address potential compliance issues. This can help to identify areas for improvement and ensure that the facility is always inspection-ready.
Train Staff. Staff training is critical for maintaining compliance and ensuring inspection readiness. Companies should provide regular training on GMP, quality compliance, internal procedures, regulation and other relevant topics.
Establish Policy. Companies should establish policies and/or procedures for handling regulatory inspections, including a process for responding to inspection observations and communicating with inspectors.
Review Supply Chain. It is expected that companies have a robust and secure supply chain. Companies should regularly review their supply chain to ensure that it is compliant with current regulatory requirements and is able to withstand potential disruptions.
Stay Informed. Companies should stay informed about changes to Agencies’ regulations and guidance, as well as emerging GMP industry trends. This can help companies to proactively address potential compliance issues, improve quality culture and maintain inspection readiness.
What are the most critical technical challenges for a consultant?
The impact of the Covid-19 pandemic led to a shift in traditional consulting models, which made consultant companies face new challenges. The consulting market, already overcrowded, is now even more competitive.
To survive, consulting firms need to rapidly react to changes and adopt new strategies. Their stability and growth will depend on the ability to analyze the business environment and come to the right conclusions.
Clients have become more demanding; now they expect immediate results, transparency, accountability, and a higher quality of work.
Basically, clients expect consulting firms to be experts, and at the same time to be reliable.
So, gaining and maintaining clients’ trust is definitely a serious challenge in the consulting field. All you can do as a consultant is to convince the customer that your professional service will be profitable for him/her in the long run.
OFTEN MOVE IN THE GRAY AREA BETWEEN THE PURE THEORY OF GMP AND ITS PRACTICAL APPLICATION IN A PHARMACEUTICAL PLANT
Quoting from FDA website’s “Facts About the Current Good Manufacturing Practices (cGMPs)”i, always keep in mind that:
“The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the c in cGMP stands for current, requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been top-of-the-line to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards”.
In Conclusion
Overall, companies can prepare for regulatory inspections by ensuring compliance, maintaining documentation, performing self-inspections, training staff, establishing procedures, reviewing the supply chain, and staying informed about regulatory requirements. By taking these steps, companies can help to ensure that they are inspection-ready and can navigate regulatory inspections successfully.
