The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during an inspection.
The MHRA investigators found that Bioplus Life Sciences disregarded restrictions imposed by a GMP certificate it received and failed to reliably report data, raising questions about the data’s integrity.
The investigation also revealed failures in “measures to prevent and detect cross-contamination” that risked cross-contamination between products, the agency said, noting that the company’s vendor approval process failed to weigh the risk of cross-contamination when introducing new materials.
In addition, processing operations for non-sterile products, including tablets, hard shell capsules and powder sachets were inadequate, MHRA said.
The agency logged the inspection report in the EU’s EudraGMDP inspection database, noting that no drug batches from the facility should be accepted by the EU while the statement of non-compliance remains in force.