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Monday, September 20, 2021 8:37:37 AM
Long ago, I worked part time in a lab for a US-based generics manufacturer undergoing certification. My understanding is that the license covers both the site and the process. When the review is done the facilities are inspected as are all of the QA, QC, Validations, and Stability SOPs against the data produced for the certification batches run. Things looked at are stuff like ingredients storage procedures, actual human work flow, temperature stability for any in-process elements as well as storage locations throughout floor to ceiling, East to West, center to corner
The two are hand in hand, the facility and the process. The license can be managed by a new service provider when necessary so long as the same process is followed, tested and documented. IMO
Recent NWBO News
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