GEBER CHEM FZE

Working Standards

Within the framework of proper distribution, Geberchemfze, at the request of the customer, searches for manufacturers of pharmaceutical substances, their initial qualifications, ordering substances of the required quality, and supplies substances to the customer.

Geberchemfze has quality agreements signed with manufacturers of API, which regulate the obligations of the requirements for the quality of the substances, change control, audits, claims, reviews, and emergency contacts. 

Company employees in China and India carry out checks and audits of selected enterprises. 

This approach allows us to guarantee not only the proper supply of products but also high-quality long-term relationships between manufacturers of substances and manufacturers of finished medicines.

Geberchemfze offers its clients implementing the GMP, system a working system based on Quality Agreements.

We sign a quality agreement with Finished Dosage Form (FDF) Manufacturer, which regulates relations regarding specific supplied substances, and relates to:

  • Change control

  • API manufacturer audits

  • Work with claims and reviews,

  • Outsourcing

  • Emergency information

 

The main document of the quality agreement is an open part of the Drug Master File (DMF), which include:

  • General information

  • Characterization

  • Control of API

  • Reference standards or materials

  • Container closure system

  • Stability

Scroll to Top