Medichem passes third consecutive FDA plant inspection
Drug Administration (FDA) inspection without any problem for the
third consecutive time.
The Spanish firm, specialised in the manufacture of active pharmaceutical ingredients (APIs), said it has now become part of "an exclusive group" of pharma companies that completed three consecutive inspections without any observation.
FDA inspections investigate not only plants' ability to meet current Good Manufacturing Practice (cGMP) standards but also frequently expose manufacturers shortcomings as the cause of production failures and the instigation of corrective actions.
cGMP regulation is a strict set of international regulations, codes, and guidelines for the manufacture of pharmaceutical and medicinal products.
Facilities operating in compliance with cGMP must be able to demonstrate that every aspect of their operations and processes are controlled, allowing for traceability in the manufacture and testing of all products.
The inspection of Medichem's manufacturing facility located near Girona in Spain, was carried out by two FDA officers last month for four days and eight different APIs were part of the inspection.
In addition, the FDA audited the management of materials, as well as laboratory and quality systems.
At the end of the last three FDA inspections, performed in 1999, 2002 and this year, no "form 483" was issued.
A form 483 is the written report that the US regulator produces to reflect and identify a list of observations and deficiencies found during the inspection. Therefore, "no form 483 issued" means that neither deficiencies nor observations have been detected.
"We are very pleased with the outcome of this difficult inspection, because it tells us that our commitment to achieve the highest quality levels is in the right direction," said Ervin Veszpémi, Medichem's CEO.
"We will now double our efforts to maintain and further improved our service levels to our customers."
This represents a positive step for Medichem as the company makes 40 per cent of its worldwide sales in the US and Canada.
Medichem, which generates a yearly turnover of €40m, said its quality systems are supported by the FDA and guarantee a consistent follow-up and continuous improvement of its manufacturing processes.
Over the last years, Medichem has developed a broad pipeline of new products in order to respond to its clients' needs. These products are indicated for the treatment of diseases in many therapeutic areas including central nervous system (CNS), cardiovascular, antivirals, antihistamines and antiasthma.
