EU Non-Compliance Report issued after insufficient CAPA

A recent EU Non-Compliance Report issued by the Maltese Medicines Authority to Cubit Lifesciences in India highlights significant observations, necessitating a detailed analysis, especially concerning Corrective and Preventive Actions (CAPA).

Following a previous inspection that identified "2 critical, 3 major, and a total of 17 other observed issues," a follow-up GMP inspection was conducted at Cubit Lifesciences early in 2024, as recommended. The purpose was to validate the effective integration of documented CAPAs and commitments across the facility and the pharmaceutical quality system, in response to the February 2023 inspection.

However, the follow-up inspection uncovered that certain issues from the initial inspection remained unresolved, resulting in "two critical, four major, and twelve other findings." This indicated inadequate implementation of necessary CAPAs. Consequently, the Inspection Review Group decided to issue a "Statement of Non-Compliance" with Good Manufacturing Practice guidelines, reflecting ongoing compliance concerns at Cubit Lifesciences.

Thorough investigation and definition of corrective and preventive actions (CAPA) are imperative to address inspection observations. Implementation of CAPA following root cause analysis (RCA) ensures appropriate actions are taken to prevent recurrence. The report underscores the importance of conducting a comprehensive root cause analysis and implementing effective CAPA measures.