Trends and Key Issues in the Pharmaceutical Industry; Quality By Design, Manufacturing Process Validation and Annex I
Optimisation of the manufacturing process validation process, and compliance with Annex I are essential for the development and manufacturing of safe and effective drugs. Current trends in the pharmaceutical industry include the application of advanced technology and process optimisation to reduce development, scale-up and manufacturing risks and optimise costs at all stages of generation and production of new pharmaceutical products.
- Quality by Design (QbD) is a systematic and scientific approach to process design and development that ensures the quality of pharmaceutical products. This approach involves the use of statistical and scientific tools to understand and control the critical process factors that affect the quality of the final product.
- The validation of the manufacturing process is a critical stage in any pharmaceutical development and is the link between the research of the product and its industrial manufacturing process, thus marking and defining crucial aspects for registration and for future manufacturing on a commercial scale. The optimisation of this process is increasingly becoming a tool to reduce risks and improve manufacturing stages and processes.
- Annex I of the Good Manufacturing Practices (GMP) is a guide that sets out the quality and safety requirements for the manufacturing of sterile products. Much of the guidance in this guide, however, can also be applied to processes and facilities outside the field of sterile products. Their interpretation and correct application is a critical issue for pharmaceutical manufacturers.
This conference gives an overview of Quality by Design and its applications in galenic and analytical development, followed by an overview of the optimisation and validation of manufacturing processes, as well as an insight into the highlights of Annex I on manufacturing.
These issues have a relevant impact on the daily activities of the R&D, quality (control and assurance) and manufacturing departments.
- Free access to the event with accreditation
- Limited capacity
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