EU Non-Compliance Report issued after insufficient CAPA

Recommendation

19/20 November 2024
Hamburg, Germany

The GMP-Compliance Manager

A recent EU Non-Compliance Report ("Statement of Non-Compliance with GMP") issued by the Maltese Medicines Authority to Cubit Lifesciences in India contains significant observations and requires the company to carry out a detailed analysis, particularly with regard to CAPA (corrective and preventive actions).

What happened?

A follow-up GMP inspection was carried out at Cubit Lifesciences in India by the Malta Medicines Authority (MMA), an EU Competent Authority, early 2024. This inspection was in line with the recommendations from a previous inspection conducted about one year earlier, which had identified "2 critical, 3 major and a total of 17 other observed issues."

The main goal of the recent follow-up inspection was to "assess and validate the effective incorporation, spanning the entirety of the facility and the pharmaceutical quality system, of the documented Corrective and Preventive Actions (CAPAs) and commitments presented by Cubit Lifesciences in response to the February 2023 inspection."

However, the follow-up inspection revealed that some issues identified in the initial inspection were "not fully addressed and implemented," leading to the finding of "two critical, four major and twelve other findings." This indicated a lack of proper implementation of the necessary CAPAs.

As a consequence, the Inspection Review Group (IRG) at the Malta Medicines Authority has decided to issue a "Statement of Non-Compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC" for the site, reflecting ongoing concerns about compliance and quality management at Cubit Lifesciences.

Also for inspection observations, the causes of the problems identified would need to be thoroughly investigated and corrective and preventive actions (CAPA) should be defined to prevent recurrence. The implementation of CAPA following a root cause analysis (RCA) is crucial as it ensures that the identified causes are addressed through appropriate actions. The report emphasises the need for an in-depth root cause analysis and the implementation of effective CAPA.