GMP Problems with critical Medicinal Products - what next?

A recent non-compliance statement by the Malta Medicines Authority reveals that Akriti Pharmaceuticals, an Indian company, fails to meet Good Manufacturing Practice (GMP) standards. This prevents Qualified Persons (QPs) from certifying batches, risking the integrity of critical medicinal products.

 A routine onsite inspection found 3 critical, 5 major, and 17 other issues, including:

• Ineffective quality management
• Data integrity issues
• Unreliable stability studies
• Poor production and packaging control
• Analytical testing deficiencies

Given the potential impact on critical products, a risk assessment was shared through the rapid alert network. No replies confirmed no affected products on the EU/EEA or MRA partner markets. Thus, GMP certificate MT/002HM/2023 was revoked from EudraGMDP.

If critical products were on the market, the statement allows QPs to certify affected batches under strict conditions, including documented risk assessments and thorough risk-benefit evaluations. This case underscores the limitations of distant assessments.