Non-Compliance at Italian Sterile Manufacturer

Recommendation

20-22 September 2022

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GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms

In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations at an Italian manufacturer. The Italian manufacturer produces aseptically prepared LVPs (Large Volume Parenterals) and powders, as well as terminally sterilised LVPs. During the inspection, deficiencies were found in the areas of sterile products (both aseptically prepared and terminally sterilised), secondary packaging and quality control (microbiological, chemical/physical and biological.

The authority has reported 17 major and one "other" deficiencies. The major deficiencies concerned the qualification of critical equipment (autoclaves, depyrogenation tunnels, lyophilisers, CCI testing equipment for ampoules, visual inspection systems). Besides, it has been observed that data integrity was not assured in the quality control equipment and that - all things considered - there was a weak system in place for the investigation of deviations.

As a result of the inspection i.e. of the deficiencies discovered, the manufacturing authorisation of the company has been suspended.

Source: EMA's EudraGMDP database