Over the years, Esapharma has implemented a set of programmed and coordinated management actions, operating procedures, documentation and registration systems that enable the company to monitor its processes and activities.
Certifications are the acknowledgment of the commitment to providing efficient management, appropriate facilities, and adequate skills, but it is also a guarantee of reliability for customers, suppliers, employees and collaborators.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently manufactured and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
The AEO (Authorised Economic Operator) concept is based on the Customs-to-Business partnership introduced by the World Customs Organisation (WCO). Traders who voluntarily meet a wide range of criteria work in close cooperation with customs authorities to assure the common objective of supply chain security and are entitled to enjoy benefits throughout the EU. The EU established its AEO concept based on the internationally recognised standards. The programme aims to enhance international supply chain security and to facilitate legitimate trade.
Esapharma received from Italian Agency, AIFA, a new authorization for the production of an Investigational Medicinal Product (IMP) of semisolid non-sterile products.