+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Consultancy on manufacturing sites and audits

The Good Manufacturing Practice (GMP) includes rules and specific requirements regarding methods, means, equipment and management of the manufacturing process of a drug in order to ensure that it has appropriate quality standards.

The main services offered in this field are:

  • Advice on new applications, variations and renewals of manufacturing authorisations for starting materials and finished products
  • Submission of variation applications and support during the AIFA assessment/approval procedure
  • Request of GMP certificates
  • Assistance to obtain authorisations for medicinal product warehouses
  • Audits to manufacturing sites of active pharmaceutical ingredients (API) and finished products, in Italy and in other EU or extra-EU countries
  • Audits to warehouses, distributors, wholesalers
  • Support during inspections by regulatory authorities and inspection follow up
  • Support in specific meetings with AIFA
  • Support on extra-EU registrations

Thanks to our experts, Di Renzo Regulatory Affairs also offers the possibility to take on the role of regulatory affairs inside manufacturing companies. This service is especially useful in the case of subcontractors and includes activities such as Change Control management with a regulatory impact, management of essential and non essential amendments, contacts with clients, regulatory compliance between dossiers and operative procedures and quality agreements.

Foto di kaosnoff da Pixabay