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Compliance

Compliance

Quality System

Our Quality system is anchored by a deep understanding of current Good Manufacturing Practices (cGMPs) and ICH Q7 guidelines. We design quality into every manufacturing process we develop and scale for you, and execute every aspect of our work to the highest standards. Whether in support of clinical development or process validation / launch planning of new chemical entities (NCEs) or life-cycle management of mature products – Porton’s multi-functional teams are focused on ensuring your product’s conformance to specifications and compliance with the quality expectations of major global regulatory agencies.

Backed by the substantial experience and expertise of our centralized corporate QA group, Porton’s Manufacturing Facilities routinely host more than 50 customer audits by global pharmaceutical companies each year, and have successfully received 5 of 5 consecutive inspections by major regulatory bodies such as the USFDA, EMA, PMDA and NMPA. 

 

Quality by Design (QbD)

Taking a proactive and scientifically rigorous approach, our Design of Experiments – based Quality by Design (QbD) strategy deploys statistics, analytics and risk management principles in the design and development of manufacturing processes to ensure optimum product performance, inter-batch reproducibility and ultimately mitigate against supply chain disruption. Using state of the art tools, Porton’s QbD specialists collectively bring decades of experience in Process R&D, Engineering, Analytics and Quality. We are proud to have helped major pharmaceutical companies successfully complete process validation programs through our QbD platform.


 

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