On the basis of a GMP inspection performed in May 2018 at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report.
In total, the Italian authority found nine serious deficiencies in the area of contamination control of premises and equipment. Also the personnel and material flows were criticised. Moreover, aseptic processing in the production area as well as the microbiological quality control and deviation management gave reasons for complaints. The aseptic manufacturing in question concerns a lyophilized API. The grave situation here is that the Italian manufacturer performs this manufacturing step as a contract manufacturer for several pharmaceutical companies. Now, the AIFA recommends suspending the manufacturing authorisation for the lyophilizing process and recalling the batches concerned insofar there is no risk of shortage. With this non-compliance report the national GMP authorities have got the information and can take the necessary measures.
According to the Italian authority, the manufacture of non-sterile APIs and medicinal finished products is not affected. You can find the report of the Italian authority (AIFA) in the EU EudraGMDP database.