Design space verification
Design space verification is defined by the European Medicines Agency as the verification that material inputs and processes are able to scale to commercial manufacturing levels while maintaining a standard of quality. Therefore, it is difficult to conduct design space verification while not operating at target levels and should be conducted over the manufacturing lifecycle. Changes in manufacturing output within the design space should not present any risks. Should the manufacturing load exceed the boundaries defined as normal operating ranges unanticipated scale-dependent issues can occur.
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Design space verification
Design space verification is defined by the European Medicines Agency as the verification that material inputs and processes are able to scale to commercial manufacturing levels while maintaining a standard of quality. Therefore, it is difficult to conduct design space verification while not operating at target levels and should be conducted over the manufacturing lifecycle. Changes in manufacturing output within the design space should not present any risks. Should the manufacturing load exceed the boundaries defined as normal operating ranges unanticipated scale-dependent issues can occur.
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Design space verification is d ...... ion of the production process.
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Design space verification is d ...... le-dependent issues can occur.
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Design space verification
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