Audit GMP

Good Manufacturing Practices (GMP) are guidelines that regulate all aspects of medicinal product manufacturing, including documentation, personnel training, facility and equipment management, and much more.

Verifying regulatory compliance through GMP audits ensures that medicines are produced and controlled according to rigorous, internationally recognized quality standards, thus protecting patient health.

In addition to being a legislative requirement, GMP audits are essential tools for Marketing Authorization Holders (MAHs) who wish to evaluate the robustness and reliability of external partners entrusted with contract manufacturing (CMOs – Contract Manufacturing Organizations; CDMOs – Contract Development and Manufacturing Organizations).

Di Renzo Regulatory Affairs has a dedicated unit with qualified experts fully dedicated to auditing and inspection activities, who conduct GMP audits at finished product and active pharmaceutical ingredient (API) manufacturing facilities in Italy and other EU and non-EU countries.

In addition, the unit is also able to carry out audits according to Good Distribution Practice (GDP) to warehouses, distributors and wholesalers of medicinal products.