![]() ![]() ![]() ![]() is it the same as or less than for non-breakthrough therapy products? What has been the experience of other firms that have explored these topics? For example, is there any allowance by regulators for some uncertainty and ambiguity of critical attributes and parameters at time of initial validation (i.e. Others may include how many ‘batches’ (however defined) maybe required, and should the shortest, longest, or standard run times/speeds be validated?Īccelerated development and validation of breakthrough therapy products also raises its own set of many questions such as at what point must critical attributes and their ranges be established – can it be during or after process validation? How much development is required prior to process validation – e.g. How much batch data are required to build the model and at what point must it be demonstrated to be accurate before process validation can be initiated? These are some of the common questions encountered during preparation for process validation of a continuous manufacturing process. Real time monitoring and control of the process such as diversion of product that does not meet critical attributes typically involves building of models to perform the monitoring and take action when necessary. For example, continuous manufacturing often relies heavily on real time monitoring of critical attributes and/or parameters. Some of the newer areas of bio process validation that will be covered include:įrom our own experience these areas raise a number of questions and potential changes to historical process validation approaches. Presentations at this event will range from case studies to approaches used for bio process development/design through to continued process verification. FDA) insights as well as industry speakers. The planning committee has worked hard to put together an agenda that includes regulatory (e.g. Maurice Parlane and Gretchen Allison are the chairs of this workshop and are excited to share this year’s agenda with you. This workshop will focus on: Challenges in Process Validation for Today’s and Tomorrow’s Next Generation Bio Products On June 20-21, ISPE will host the 2019 ISPE Process Validation Workshop at the Boston Renaissance Waterfront. ![]()
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