Controlling contamination of sterile drug products has been a major challenge for the pharmaceutical industry for years. It has been a major cause of recalls and regulatory actions not just in emerging economies but in US, EU and other first world economies alike. This is despite the wealth of knowledge of sterile drug manufacturing processes, most current technology and improved testing methods.
Apart from CCS, there are variations in the filtration design, set-up, operation, process stream attributes, and manufacturing operational philosophies all have a significant impact on how pre-use/post-sterilization integrity test PUPSIT is incorporated into a manufacturing process.
This workshop will try to address and equip you with the key points of how to avoid a product contamination and establish and maintain a state of control for microbial and particulate contamination. It will also show that there is not a "one size fits all" solution for PUPSIT implementations.
Key takeaways
Who Should Attend
Auditors, Biotech Managers, Head of Plant, Head of Quality Compliance, Engineering Managers, Microbiologists, Product Managers, Production Managers, Packaging Specialists, Quality Assurance Managers, Regional Sales Managers, Regulators, Regulatory Inspectors, Quality Control Managers, Quality Operations Managers, Regulatory Specialists, Scientists, Sterile Processing Specialists, Technical Account Specialists, Technical Directors, Unit Managers