Sandoz Pharmaceuticals Gebze Generic Drug Factory

Sandoz Pharmaceuticals Gebze Generic Drug Factory

2006–2009
Kocaeli / Gebze
Sandoz Pharmaceuticals

Project Summary

In this project carried out between 2006 and 2009 at the Kocaeli / Gebze location, Envora Global provided project management services for Sandoz Pharmaceuticals in collaboration with its partner ELİKSİR. The project area mentioned in the presentation is 4,000 m². The study addressed topics such as the improvement of GMP practices, the EU-GMP documentation system, quality control, and microbiology laboratory renovation. Additionally, works were also conducted on the renovation of HVAC, DI water, and compressed air infrastructure, solid, liquid, and semi-solid form areas, pellet production area renovation, and preparation for FDA inspection. The project is among the reference projects completed jointly by Envora Global and ELİKSİR.

Sandoz Pharmaceuticals / Elixir Partnership

Envora Global, in collaboration with its partner ELIXIR, has conducted project management-focused work for Sandoz Pharmaceuticals at the Kocaeli / Gebze location. According to the information in the presentation, the project has been implemented in an area of 4,000 m². This work is one of Envora Global’s reference projects in GMP consulting for generic drug factories.

During the project, collaboration took place on improving GMP practices, EU-GMP documentation systems, quality control and microbiology laboratory renovation, HVAC, DI water and compressed air infrastructure renovation, solid, liquid, and semi-solid form areas, pellet production area renovation, and preparation for FDA inspection. The project was completed between 2006 and 2009.

If you are planning GMP consulting for a generic drug factory or a similar facility project, contact Envora Global; let’s evaluate your needs together. You can also check our other pharmaceutical factory and GMP-compliant production area projects.

Project Scope

Improvement of GMP practices
EU-GMP documentation system
Quality control and microbiology laboratory renovation
Renovation of HVAC, DI water, and compressed air infrastructure
Solid, liquid, and semi-solid form areas
Pellet production area renovation
Preparation for FDA inspection

Project Results

Proje Alanı
4,000 m²
Hizmet Türü
Project management
Üretim Kapsamı
Generic drug; solid, liquid, and semi-solid forms, pellet production
Uyum Standardı
EU-GMP, FDA
Proje Durumu
Completed (2009)

Customer

Sandoz Pharmaceuticals

Catalog

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