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As a leading pharmaceutical analytical solutions provider and based on ICH-Q8 QbD and scientific cognition, AUSTAR integrates quality into products and processes by design, reflecting our understanding of product, processes and expected product internal quality control capability. With understanding of the impact of formulation and ingredients (especially CMA) and process parameters (especially CPP) on product quality, and through off-line and on-line analysis and detection technologies to achieve continuous monitoring and feedback updates from R&D to production. In addition to suggestions on the development of analysis methods and corresponding detection equipment in the early stage, AUSTAR can also provide ICH-Q8 based analysis method validation in the later stage to achieve whole process quality analysis and detection technology, from analytic procedure development to validation, from R&D to production, from raw materials, semi-finished products to finished products.

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Development and validation of laboratory analytical method

The main purpose of R&D laboratories is to carry out research and development of new products, and the quality control of products is the basis and premise for ensuring drug safe and efficacy, and appropriate detection methods could help ensure quality control. Therefore,in addition to combining the material properties, relevant research data, guidelines and theories, the analysis technology should also combine current analysis and detection technology with the detection accuracy of the equipment.

AUSTAR risk management conducts systematic research and evaluation on various parameters, through designing reasonable tests to measure analysis method meet testing targets and set reasonable standards. In addition to the development of analytical methods, we could also help with corresponding validation drafts in according to ICH-Q2 guidelines.

PAT Process analysis technology

Quality analysis in R&D and production process shall have reliable analysis & detection methods and appropriate means supporting these methods. Process analysis, as an important part, is playing an increasingly important role in the context of continuous mass-manufacturing. AUSTAR can help clients not only get the expected product quality test results, but also obtain the multivariate data from the process analysis results to achieve process monitoring purpose, and it is also an information source for maintaining constant quality and continuous improvement.

PAT(Process Analysis Technology)has the characteristics of rapidness, timeliness and high efficiency in the process from R&D to production, from quality parameter analysis to process parameter control. It is a solid foundation for continuous production and could avoid the defects of traditional analysis and long cycle detection length or delayed test results caused by non-conformance of product monitoring, it would be a powerful supplementary for future high-efficiency production. Guided by PAT technology, AUSTAR provides clients with integrated solution covering each process link (Biopharmaceutical,chemical synthesis, crystallization process, and essence extraction), assisting in pharmaceutical development and production.

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