Control system for radiopharmaceuticals

A system for use in managing a process of manufacturing a plurality of batches of a radiopharmaceutical at a facility, the method comprising:

• a database configured to store data;
• at least one processor connected to a network, wherein the processor is programmed to:
• receive data relating to performance of the process of manufacturing a first batch of the plurality of batches of a radiopharmaceutical;
• generate information about the process of manufacturing the first batch;
• use the generated information to determine whether a first problem occurred during the process of manufacturing the first batch and/or whether a second problem is likely to occur during manufacturing of a subsequent batch;
• based on the determination, analyze the first problem or the second problem to determine whether to proceed to a manufacture of the subsequent batch;
• and
• generate an indication based on the analysis of the problem.

A method of managing a radiopharmaceutical manufacturing process in which each of a plurality of entities performs at least a portion of the manufacturing process at a facility operated by the entity, the plurality of entities including a first manufacturing facility that manufactures a pharmaceutical compound and a second manufacturing facility that synthesizes the radiopharmaceutical in multiple batches using the pharmaceutical compound manufactured by the first manufacturing facility, the method comprising:

• at a data processing location, receiving and aggregating data from each of the plurality of entities, the data received from a respective one of the plurality of entities relating to performance of manufacturing equipment in the respective at least a portion of the manufacturing process performed at the facility operated by the respective entity, wherein the step of receiving the data comprises conditionally receiving the data based on a security key associated with that data, the security key being provided by the respective entity;
• with at least one processor at the data processing location, generating information about the manufacturing process based on the received aggregated data, wherein generating information comprises generating a trend analysis of at least one parameter of the manufacturing process based on the aggregated data;
• and
• using the generated information trend analysis to predict a problem comprising one or more of:
• a systemic problem with an underlying recipe for synthesizing the radiopharmaceutical;
• an excursion of at least one manufacturing process parameter of the manufacturing process that may lead to out of specification pharmaceuticals;
• or
• a future infirmity in a radiosynthesis process performed by one or more of the plurality of entities;
• producing an output indicating a characteristic of or adjustment to at least a portion of the manufacturing process, the characteristic indicative of the predicted problem;
• and
• providing the output to be implemented by at least one of the plurality of entities.