Saga Lifesciences Limited — EU GMP NCR (EudraGMDP) Findings

A follow-up GMP inspection was conducted at the aforementioned site by MMA, as an EU Competent Authority, executed during the period of November 24th to November 29th, 2023. The inspection’s focus, as a follow up inspection, was aligned with the recommendations stemming from a previous GMP inspection conducted between November 10th and November 15th, 2022. The previous inspection had resulted in the identification of three major deficiencies, among a total of seventeen other observed issues. The principal objective of the 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 Saga Life Sciences in response to the November 2022 inspection. During the follow-up inspection the inspectors found three critical, two major and six other deficiencies, some of which were already identified in the initial November 2022 inspection and still found not fully addressed and implemented in the follow-up inspection, indicating an improper implementation of all CAPAs throughout the whole facility. As a result of this outcome, the Inspection Review Group (IRG) at the Malta Medicines Authority has met and decided that a Statement of Non-Compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC is to be issued for the site. Main inspection findings were three critical and two major reported deficiencies were found during the course of the follow-up inspection. The critical findings were related to (1) Failure of certain measures in place that guarantee the conservation of pressure cascade systems during manufacturing operations to prevent cross-contamination. As stated in the introduction above, this failure had already been identified in the November 2022 inspection and is now being upgraded from a Major to Critical finding. (2) Improper cleaning of major manufacturing equipment. (Equipment labelled as clean was still observed to be visually dirty), and cleaning validation activities that were inadequate to prevent cross-contamination of products. (3) Issues in QC laboratory that included data integrity breaches. The major deficiencies were found in the areas of (1) Self-inspection program was found to be inadequate and (2) Several bad documentation practices were observed throughout the course of the inspection. For further details the post-inspection letter (dated: 18th December 2023) that lists all findings is available by request. Action taken/proposed by the NCA: Others GMP Certificate number MT/026HM/2019 will be withdrawn from the EudraGMDP database and a statement of GMP non-compliance will be issued.