Telstar offers consultancy service for QbD systems
Following acquisition of dTC Development Team Consulting
Telstar, a global engineering, construction and services solutions provider to the life sciences industry, is to offer a new Quality by Design (QbD) deployment service, while expanding its R&D quality systems service for the preclinical (GLP) and clinical (GCP) phases in the development of active ingredients and drugs.
The expansion of the Spanish company’s consultancy services portfolio took place earlier this month when it acquired Barcelona-based dTC Development Team Consulting.
dTC Development Team Consulting, established in 2000, is a specialist in executing projects that deal with GXP regulatory compliance and with the improvement of manufacturing processes based on QbD concepts.
With the integration of dTC's expertise into its business, Telstar claims to be the only Spanish company capable of offering a global pharmaceutical consultancy service that encompasses the entire drug life cycle.
QbD in product development, manufacturing and marketing of drugs and APIs is aimed at achieving robust and efficient processes
QbD in product development, manufacturing and marketing of drugs and APIs is aimed at achieving robust and efficient processes, leading to a quality assurance for the product with the optimisation of costs. Efficiency in manufacturing processes reduces inspection efforts and product related non-quality costs. It is a competitive methodology when compared with a traditional quality assurance system based primarily on final inspection and control.
The regulatory framework to work in QbD is now established, and the latest GMP updates require adapting quality systems to new, risk management-based models, and adapting production systems to permit continuous process monitoring and verification. As of January 2013, the US FDA requires the use of QbD methodology for the drug marketing authorisation process of generic products.
Telstar says the integration of this specialised service enables the company to position itself as a leading provider of GLP services for non-clinical development, GCP services for clinical development, QbD services for process development and redesign, PAT/NIR services for process monitoring and control and GMP services for GMP production and operational excellence.
