Zenzi Pharmaceutical Industries Private Limited — EU GMP NCR (EudraGMDP) Findings

An onsite GMP inspection was conducted following an application received by the company (Zenzi Pharmaceutical Industries Private Limited), to assess compliance with EU GMP guidelines. The company was previously granted EU GMP certificate DK/H/10000/726 dated 01/05/2023 following an EU GMP inspection conducted on 10/02/2023 (last day of the inspection). Since this inspection the business in the EU shifted from Dune Medicare ApS, Denmark to Forza Advance Limited, Malta with respect to responsibility for EU Batch Release. Three years since the last GMP inspection elapsed on 10/02/2026. During the onsite inspection performed between 26th – 31st March 2026, the inspectors observed 2 Critical, 7 Major and a total of 17 Other issues. The first critical finding related to the Pharmaceutical Quality System (PQS). The management and documentation of the PQS was found to be severely lacking in various aspects. The Quality Assurance department was also not adequately resourced. Senior management leadership and active participation was not ensuring an effective PQS. The headcount at QA was a total of 6 personnel shared between the inspected Oral Solid Dosage Block and a Sterile Injectable block (out of this inspection’s scope). From the inspection findings and observations made it was clear that the QA department was not able to maintain an adequate PQS and could not respond to the inspection requests effectively. Control of documentation was not in place to ensure that documents are current, effectively updated and securely distributed. High-level documents were not current at the time of their effectiveness, nor identified for revision at the time of the inspection. The management of change control, deviations, risk assessments and good documentation practices within the organisation were also found to be severely lacking. The second critical finding related to Data Integrity violations which were observed during the inspection. Various Logbooks/Registers were present in various forms other than hard bound, ranging from clipped with different paper and ink, stapled and loose papers in plastic folders. Evidence of reissued parts of logbooks replacing original parts were observed during the inspection. This raised serious concerns related to integrity and reliance on logbooks’ content. Other data integrity concerns included backdating practices which were observed three times on two occasions during the course of the inspection. Audit trail was disabled from chromatographic sequences in QC analysis. The password complexity policy for software was not enforced with high protection requirements. Deliberate false information was given to the inspector for the password length setting set by IT administrator in the Agilent Open Labs software. Sequence files for HPLC and GC were in folders with read/write access allowing renaming and deleting of data by analysts. Sequence files whose analysis was reviewed complete in one month showed modified dates in another month. Seven “Major” findings were identified related to supplier qualification, training and medical examination of employees, temperature mapping, primary and secondary packaging operations, Quality Control operations, sampling, and storage of API not in accordance with the product labelling. 17 findings which were classified as “Others” were also identified. 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 (EU) 2017/1572 is to be issued for the site. Action taken/proposed by the NCA: Others Member states should consider whether review of any current active marketing authorisations is necessary and should consider not initiating or authorising new marketing authorisations with this site listed as a finished product manufacturer until the recommended non-compliance statement to be issued remains in place.