ISPE India is excited to present 2020 annual conference in Mumbai, India to discuss advances & new Frontiers in Sterile Manufacturing Technology.
The event this year will bring some key international experts representing Pharmaceutical and Bio pharmaceutical Industry to take a look at Technological Innovation, Emerging Global GMP regulations, current industry standards and some exciting new approaches to meeting product quality requirements.
- The main focus of the conference will be novel techniques, equipment and technology, including the single use technology for commercial manufacturing which are constantly evolving and which are improving aseptic production capabilities.
- The second focus area will be the European Medicines Agency’s Annex 1 so as to have a common understanding of the right approach in its implementation , understand exactly what is required and its implications on microbial monitoring.
- The third focus area of the conference will be highly potent/toxic products, which demand more stringent requirements for cleaning in multi-product facilities to prevent cross-contamination and provide occupational safety for the operators.
- The fourth focus area of the conference will be rapid microbiological testing which can enable us to get product test results faster, allowing us to make the most appropriate decisions about our batches, saving valuable time and ensuring that product can reach the patient as quickly as possible while still assuring safety.
- Other area like energy efficiency of the Heating, ventilation and air conditioning (HVAC) which within regulated environments is typically responsible for consuming up to 40-80% of a site’s total energy will also be discussed.