The MHRA has found AI-generated answers to inspection questions are often “repetitive and lack context.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted the risks of using artificial intelligence (AI) to generate responses to inspection queries, particularly in the field of Good Manufacturing Practice (GxP).
The agency has identified examples of submissions from companies that have used AI to answer questions posed during GxP inspections. However, these AI-generated responses often lack context, are repetitive, and may not fully address the concerns raised.
A Double-Edged Sword
The Fine Line Between Efficiency and Compliance
The MHRA’s concerns are not about the use of AI itself, but rather how it is being used to generate responses that may not meet the regulatory requirements. While AI can be a powerful tool for streamlining processes and improving efficiency, it must be used in a way that ensures compliance with regulatory standards.
Setting Standards for AI-Generated Responses
The MHRA is now working to establish clearer guidelines on the use of AI in GxP inspections. This includes developing standards for AI-generated responses to ensure they are accurate, contextual, and compliant with regulatory requirements.
What this means
For companies operating in the pharmaceutical and medical device sectors, this means being cautious when using AI to generate responses to inspection queries. While AI can be a valuable tool, it’s essential to ensure that any generated responses are thoroughly reviewed and verified to ensure compliance with regulatory standards.
