Malta Medicines Authority Maintains cGMP Non-Compliance Statement of Akriti Pharma

Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in a state of non-compliance with EU GMP requirements. In an update to the initial Non-Compliance Statement (NCS) MT/001NCR/2024 issued on 6 May 2024, the Malta Medicines Authority (MMA) stated that reinspection of the facility in July 2025 resulted in six Critical and nine Major observations along with a number of findings classified as Others. The critical observations include:

• Falsification and inconsistent records,
• Severe findings and short comings in production, packaging, quality control, calibration, qualification, validation,
• Unsuitable cleaning and monitoring processes for control of cross-contamination

Major observations cited include:

• Deficient training and management of employees,
• Deficient temperature and humidity control in process rooms,
• Deficient QMS practices – change control, deviations, CAPA management, document control,
• Deficient sampling and dispensing processes,
• Deficient procedures in water systems management,
• Issues in warehouse processes.

The facility which manufactures non-sterile solid dosage forms, tablets and capsules was issued a Statement of Non-Compliance in May 2024 by MMA, following serious cGMP violations identified during an inspection in April 2024. This inspection identified 3 critical, 5 major and 17 other observations. The critical observations included Ineffective implementation of the quality management system, data integrity issues, and unreliable stability studies. The reinspection in July 2025 was conducted following a request by the Company for assessing the compliance with EU GMP requirements and improvements promised by the Firm.

• Update to Akriti Pharma NCS (August 2025)