What happened
After the inspection ending 15 September 2026, the Malta Medicines Authority considered the site non-compliant for non-sterile pellet manufacture and quality-control testing. A critical deficiency concerned contamination risk in cleaned fluid-bed coating equipment: liquid pooling and residue were observed in an inlet-air plenum. The authority linked this to a design that prevented gravity drainage and an inadequate cleaning procedure. There was also no real-time differential-pressure monitoring before and after the supply-air HEPA filter to detect integrity failure. Eleven major findings covered production records, process and cleaning validation, differential-pressure excursions, warehouse, sampling and dispensing controls, vendor qualification, starting-material identification, excipient risk assessments, OOS handling, equipment qualification and pest control. The authority stated that no site-manufactured batches should be released to EEA markets while the statement remains in place, unless superseded by an EU GMP certificate. Under the revocation heading, it recommended that member states consider not initiating or authorising new marketing authorisations listing the site; it did not state that existing authorisations were revoked. The authority said products should not be present in EEA markets and did not propose a teleconference.
Why it matters
The reported pooling and residue in cleaned coating equipment indicate a contamination risk, compounded by drainage design and cleaning weaknesses. The absence of real-time differential-pressure monitoring may limit detection of supply-air HEPA filter integrity failures. Broader findings indicate that controls were not adequately demonstrated across process reproducibility, pellet homogeneity, cleaning, materials receipt and handling, supplier oversight, OOS management and equipment qualification. Any exceptional batch certification for critical products would be subject to the risk assessments, mitigation measures and authority confirmations described in the statement.
Key topics: Liquid pooling and residue in cleaned fluid-bed coating inlet-air plenum, Missing real-time differential-pressure monitoring across supply-air HEPA filters, Deficient process validation, cleaning validation and material controls
Report details
- Report number: MT/004NCR/2026
- EudraGMDP document reference: 188112
- Site: Glukem Biocare Private Limited
- Country: India
- Inspection end date: 2026-09-15
- Issue date: 2026-10-16
Source: EudraGMDP – Statement of GMP Non-Compliance. Report number: MT/004NCR/2026; document reference: 188112.