Italian regulator slams simvastatin-maker Krebs for GMP deviations
The Italian Medicines Agency(IMA) detailed its concerns about Krebs in a post on the EudraGMP database last week.
Agency inspectors who visited the site – known as Plant Unit II - in March identified 24 deviations from good manufacturing practices (GMP) standards, including major deviations in crystallization, finishing and quality control testing procedures.
“The combination of the findings demonstrated a critical risk to public health, as the weaknesses of the company’s quality management system and the approach in several GMP areas such as facilities, material management, quality of the water used in the production and QC tests, were not robust enough to sustain a GMP compliant level.”
The IMA advised national authorities to assess MAHs for products for which Krebs supplied the API to see if recalls are needed, adding that: “Given the nature of non-compliance, assessment should include a complete retest of all imported batches of active substance.”
It also said: “Prohibition of supply is recommended unless there are not alternative suppliers and there is a risk of shortage” adding that “this supplier should not be approved in any new/ongoing application.”
Krebs’ main product is the lipid lowering API simvastatin.
Bombay Stock Exchange listed Krebs did not respond to a request for comment.
