20/21 November 2019
GMP Compliance problems found at more and more manufacturers in India have become a major concern of EU and FDA regulators. Again, the FDA has issued an Import Alert for an Indian Manufacturer. The company Canton Laboratories in Baroda India produces APIs. This Import Alert follows other enforcement actions initiated by FDA and EU regulators.
Again, data integrity is a major problem at the Canton Laboratories site. The Warning Letter describes for example that the firm reported microbial limits results on CoAs for three API batches without performing these tests. But the company also lacks of adequate cleaning procedures of the equipment. The inspector stated that during three separate walk-throughs of the facility taking place over five days, the inspectors found what appeared to be product residue despite the “clean” label on the equipment. This represents a potential for cross-contamination of the APIs manufactured in this equipment.
In addition, the FDA found a list of further major GMP deviations such as:
- Failure to properly investigate customer complaints.
- Failure to properly investigate out-of-specification results.
- Failure to follow your Master Validation Plan for process validations or equipment calibrations.
- Failure to provide adequate resources to the quality unit.
- Failure of your quality unit to properly review production records and detect instances where testing was not performed to support your company’s certifications on your COAs.
- Failure to perform appropriate stability studies for product currently in the market.
- Failure to establish an impurity profile for product currently in the market.
But not only FDA Inspectors have found major GMP problems. Also EU Inspectors are taking actions against a number of Indian manufacturers. In fact, the EudraGMDP database might currently list more Indian companies out of compliance situations than the US FDA. In total, 38 GMP Non Compliance Reports for Indian Manufacturers are available in the public database.