Lloyd's Register Serentec has formed a new practice group to provide process analytical technology (PAT) services to pharmaceutical manufacturing clients worldwide.
Serentec , which specialises in supplying compliance tools to industries regulated by the US Food and Drug Administration, said that PAT services are a natural extension of its existing portfolio of process and automation systems validation consulting services.
PAT is a system for designing, analysing, and controlling manufacturing through measurements of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality at the end of the manufacturing process.
The move is a timely one, given that the FDA has just kicked off a programme to encourage the adoption of PAT by the pharmaceutical, healthcare and food industries.
According to the FDA's Centre for Drug Evaluation and Research (CDER), while Americans have the highest quality drugs in the world, the process used to produce them can be expensive and wasteful.
With appropriate instrumentation, tools and techniques, PAT continually monitors the process by acquiring electronic data, evaluating statistical models and analysing parameters critical to product quality. Analysing the data gives manufacturers valuable insight into chemical, microbiological, physical, mathematical and risk factors, and allows them to focus on the quality of the entire process rather than on only the final product.
To help pharmaceutical manufacturers with the regulatory aspects of implementing PAT and to provide technical support and guidance throughout the implementation, Lloyd's Register Serentec has developed a four-step methodology to discover, develop, demonstrate and deploy PAT; each representing a key element of a successful implementation.
Various tasks and activities are involved in each step, according to the company, such as analysing proposed or existing processes, identifying critical control points, substantiating statistical correlations, locating analytical technology solutions, assembling a PAT dossier, training personnel and implementing procedural changes, integrating validation activities, and preparing FDA submissions.
The company is also hoping to set up strategic partnerships with companies specialising in software, automation, and data acquisition tools in order to provide a complete PAT solution to clients.