9/10 September 2021
After FDA and EU have raised concerns about Good Manufacturing Practice implementation at a number of Indian companies, now the Word Health Organisation (WHO) also found serious GMP deviations. The company Svizera Labs located in Mumbai, India, received a Notice of Concern - a letter similar to the FDA Warning Letters.
The Notice of Concern was sent to Svizera Labs on September 2nd 2015. A four day inspection by WHO Prequalification Team took place from 4 to 7 June 2015. WHO allowed the company to comment on the findings found during the inspection. But the WHO Team was not satisfied with the comments made by Svizera Labs.
The WHO Inspectors found serious GMP deviations as well as manipulated data. Again and again this is a finding at Indian companies and it seems to be systematic failure which is not limited to a few "uncontrolled" companies.
In the current case the dissolution test results were manipulated and - very unique - the manipulation happened while the inspectors were present! It is not known from EU and FDA inspections that inspectors have asked lab personnel to perfrom certain tests in order to check the procedure. But WHO inspectors did exactly that, and during the test performance they observed a manipulation because one of the solution vials inside the auto-injector was switched - without notifying the inspectors. The company came up with an explanation for the switched auto-injector, but the test failed. The company decided to run the test again overnight while the inspectors were not present. And the test passed the acceptance criteria. But the inspectors had doubts and when the inspectors asked the analyst to perform the test again, the results were different to the test the company had run overnight.
The Notice of Concern also lists further serious GMP violations. It seems that the company lied on different occasions when inspectors asked employees of the company. For example about the number of pipettes they were using in the lab. The company also performed several analyses, e.g. with HPLC. However, there were no records and data. These were found to be deleted for several test runs. Moreover, the company was not able to restore data that were archived or backed-up for HPLC equipment. There were no training records available for an analyst who had already been working in the lab for one year prior to the inspection. These findings are only an excerpt of the many more serious findings - such as cross contamination, failure to provide clean air for manufacturing, inadequate hygiene etc.
The WHO decided to withhold all new products manufactured at the concerned manufacturing site.