cGMP compliant design approach

Establishing a cGMP compliant manufacturing facility, implementation of lean and efficient manufacturing processes, logical material- and personnel flows, best value investment costs and in case of an upgrade, the least amount of down time are targets of pharmaceutical manufacturing companies intending to upgrade their facility or to establish a new plant.

The client’s major challenge at the beginning is to define the very basic user requirements and transfer them in to a proper project definition with a feasible scope of work, a realistic cost estimate and time schedule. The lack of a well defined URS will lead to time and money consuming misguided developments.

This is precisely why Uhde plus Chemgineering’s professional know how and experience is most appreciated by our clients. We ask the right questions, focus on the important issues and assist the client in structuring the project when required with various value add ideas and innovations with respect to the business case.

International regulatory and auditing authorities are more and more inclined in today’s market to request a risk based approach, inclusive of comprehensive traceability for all identified risks.
In order to meet these particular requirements the right procedures must be implemented up front at the beginning, and during the design phase. Uhde plus Chemgineering provides well established tools and working procedures with respect to a risk based approach, thus supporting and identifying client risks, and ensuring appropriate, traceable measures.

Biotechnology is a key to success for the future of Pharma industries. Recent advances in genomics, proteomics and virology enables the development of modern biopharmaceuticals. As recently as a few years ago, the number of innovative Biologicals exceed the number of new chemical entities. Innovative medicines require state of the art plant engineering and cutting edge technology, as provided by Uhde plus Chemgineering.  

Uhde plus Chemgineering in a nutshell
Uhde is a process-orientated plant construction company. With its comprehensive range of services, Uhde is in a position to meet the specific requirements of its customers in the Chemical and Pharmaceutical Industries.

Chemgineering is a technology and business designing company with its Headquarter in Switzerland with excellent Know How in the pharmaceutical, biotech and the life science industries.

Uhde plus Chemgineering offers consulting and engineering services for the life science industries in South Africa, our offices are located in Sunninghill, Sandton, in Johannesburg, with 300 employees representing the various engineering disciplines.

Uhde plus Chemgineering is ideally suited to provide you with the appropriate know how to assist with the various services like: Process Engineering, Qualification / Validation, Clean room design, HVAC, Electrical, Mechanical, Computer Software Validation, Logistics, Project & Construction Management, Procurement and cGMP Knowledge.

Uhde plus Chemgineering, Siegbert Weber, 71 Nanyuki Road, Sunninghill, +27 11 236 1000

 
| nach oben    | zurück    | Link zu dieser Seite versenden    | Seite drucken