Zim Laboratories Limited — EU GMP NCR (EudraGMDP) Findings

1. Nature of non-compliance: The inspection was carried out as EMA centralised GMP inspection by the Local Government of Düsseldorf as lead authority and INFRAMED I.P: as supporting authority between 28th June and 4th July 2025. The company applied for a GMP certificate with an scope of: Tablets, capsules, powder for oral suspension, oro-dispersible firlms ,sublingual films, primary packaging, secondary packaging quality control, storage and distribution. During the inspection two critical and seven major findings were observed so that the inspection team decided that a statement of non-compliance with the principles and guidelines of GMP laid down in Commission Delegated Regulation (EU) No. 1252/2014 and Commission Directive 2003/94/EC of 8th October 2003 is to be issued about the site. The GMP inspection report will contain more details about the origin of the non-compliance and will be available at EMA shortly. The critical findings are related to critical deficiencies in data integrity throughout relevant documents such as log books, CoAs and maintenance reports as well as fraud on one logbook of the HVAC in building No. 1. The major findings are related to inacceptable conditions during the production of pellets within the manufacturing room (sticky and dirty ground floor), no quality assurance control performed on specifications, sampling booth in building No. 6 with unlocked and uncontrolled backdoor and unlockable doors, unvalidated use of excel for QC calculations, non-functional differential pressure throughout several corridors, non-investigated temperature deviations in stability study room in building No. 1, no environmental monitoring in all GMP areas and unclean cleaning-equipment in LAFs. Action taken/proposed by the NCA: Others Market actions should be determinated by each Member State based on QRM principles in order to avoid shortages of medical products in the market. Additionally, no marketing authorisation applications, line extensions or variations to existing marketing authorisation applications should be authorised for the time being. No GMP certificate should be issued unless a further inspection finds this site to be fully compliance. Finally, member states are recommended to on contact the corresponding MAHs for NAPs/MRPs/DCPs for product specific impact assessments.