Overview:

In many pharmaceutical manufacturing processes, but particularly in biopharmaceuticals, combinations of manual and automated steps must be performed in a coordinated manner. In addition there are requirements to track material genealogy, equipment status, and prepare batch records for regulatory submittal.

Typically, these problems are solved by installing two distinct manufacturing systems, a manufacturing execution system (MES) to direct manual operations and perform material tracking, and a process control system (PCS) to control automated operations. But a two system approach has the following issues:

• Operator effectiveness is compromised since:
  + Operators are running operations with two separate manufacturing systems with different HMI’s
  + Separate systems result in the operator taking manual actions to transfer information between the two
  systems or perform calculations increasing the risk of data errors.
• There is no common product specification and recipe management. Each system has its own recipe
  management; again increasing the chance of human error.
• There is no common data management making implementation of electronic batch records (EBR) very difficult
• Any operability between the systems requires custom interfaces that raises concerns with regards to project risk, costs, and validation effort