China's new GMP regulation has come into force on 1st March, 2011. There are only 154 out of 5000 pharmaceutical companies in China who has passed the new GMP inspection until the end of 2011. Those manufacturing sterile drug products such as blood products, vaccines and other injectable drug products will be required to comply by 31 December, 2013, while all other facilities will have until 31 December, 2015.
Over 5000 Chinese pharmaceutical companies are facing challenges in the context of "hardware and software"updates:
•How to understand the relations between the new GMP and drug quality management system?
•How to implement practical measures to build quality management system?
•How to deal with the deviation and change during production process?
•How to proceed with process verification on sterile drug products and improve quality?
•How to keep the balance between quality and cost?
The new GMP is focused on strengthening management, enhancing hardware requirements, encouraging quality and risk management innovation. It is more scientific, instructive and operable. Pharmaceutical companies need to improve their production process, quality standard control and the verification techniques, especially in the aspects of sterile drug products, employee training and registration optimization.
Pharma Manufacturing & Quality Management China 2012 will gather 120+ decision makers from both government institutions and pharmaceutical companies to discuss hot topics including quality management system, API manufacturing, solid dosage form production and sterile drug products. It will provide a interactive communication platform for professionals in pharmaceutical industry to benchmark your business and technology against ‘best in class’ and ensure that you have the tools you need to form a coherent and logical strategy.