Danish regulators slam Indian API maker for GMP failings
The facility, inspected on December 7 last year by the Danish regulators, received a certificate of non-compliance with Good Manufacturing Practice (GMP) details of which were posted on the EudraGMP website.
The facility located in Mehsana, in the Gujarat region of India makes the active pharmaceutical ingredient (API) Psyllium HUSK, an herbal product consisting of plant fibres for dietary and herbal medicinal products. According to the Danish Medicines Agency, the product made by Kadam is only used as an API in Denmark.
According to the report, there was a general lack of ability by the firm to adhere to the principles of GMP for production facilities, laboratory facilities and storage of reference and retention samples.
“Examples of non-adherence are: The production facilities were not appropriate for GMP use. There was a big risk of contamination of products. The whole facility was not in a protected and controlled environment,” the certificate states.
“Also the laboratory facilities were not in a protected and controlled environment. Reference and retention samples were not stored in a controlled container. The personnel was not trained in EU GMP guidelines. As a result the quality of the product is not ensured.”
As a result of the inspection, Kadam’s certificate No DK API-H 00049515 will not be renewed.
