Biopharmaceutical Batch Recipe Review by Exception
A biopharmaceutical manufacturing control system and associated methods are disclosed herein.
1 . A method of producing a biopharmaceutical, comprising:
a) providing a first recipe step during biopharmaceutical manufacture to an operator;
b) detecting an exception to the first recipe step;
c) providing corrective action during biopharmaceutical manufacture to obviate the exception against acceptance criteria;
d) confirming that the corrective action was implemented; and
e) producing an automated batch record memorializing the corrective action taken.
2 . The method of claim 1 , wherein steps b), c), and e) are automated steps.
3 . The method of claim 2 , wherein steps b)-e) are automated steps.
4 . The method of claim 3 , wherein steps a)-e) are automated steps.
5 . The method of claim 1 , wherein step c) is an automated step that is implemented manually by an operator.
6 . The method of claim 1 , wherein step d) is determined from operator input.
7 . The method of claim 1 , wherein the first recipe step comprises a step of obtaining an ingredient container and scanning the container into a manufacturing execution system.
8 . The method of claim 7 , wherein the first recipe step further comprises checking the quality status of the ingredient container.
9 . The method of claim 8 , wherein an exception is detected and the corrective action comprises obtaining a replacement ingredient container.
10 . The method of claim 9 , wherein the method further comprises checking the quality status of the replacement ingredient container.
11 . A biopharmaceutical manufacturing control system, comprising:
a manufacturing execution system; and
an exception control module implemented on the manufacturing execution system that is configured to detect an exception to a process step prescribed by the manufacturing execution system and provide remedial action for the exception.
12 . The system of claim 11 , wherein the manufacturing execution system is implemented by a batch executive and configured to receive an input.
13 . The system of claim 11 , wherein the system further comprises a client terminal.
14 . The system of claim 13 , wherein the manufacturing execution system is configured to receive an input from the client terminal.
15 . The system of claim 11 , wherein the system further comprises a peripheral scanning device.
16 . The system of claim 15 , wherein the manufacturing execution system is configured to receive an input from the peripheral scanning device.
17 . A manufacturing execution system, comprising: an exception control module.
18 . The system of claim 17 , wherein the system comprises at least one client terminal, at least one server computer, and at least one controller.