by Michael McClellan
A primary cost ingredient in manufacturing pharmaceutical products is the time and effort required to build the master batch record (MBR) after the processing steps have been completed. Gathering information from the wide variety of sources and confirming compliance is an expensive but necessary part of the business.
The so-called electronic batch record (EBR) is a good first step but is costly and usually addresses only a portion of the information required to confirm batch compliance. There have also been some ideas of aggregating data and using pass/fail strategies, but these ideas require systems integration at the machine control and information technology system levels and can be very rigid and expensive.
What is needed is an easy method to extract data from each information source to build an electronic file to match the master batch record format. The next step after the file has been populated with current data would be to compare that data to the batch standard (in real-time) for the immediate reporting of deviations. In the absence of deviations, the batch could be released.
This idea would not eliminate those instances where human involvement is necessary but it certainly could make the remainder of the MBR build a lot easier and faster. The benefits from this approach seem significant and include:
- Reduced cycle time
- Reduced inventory
- Reduced data entry errors
- Improved visibility of production and process exceptions
- Rapid return on investment
Current automation technology should be able to provide these capabilities. What is so difficult about automating the MBR construction process? Every manufacturing and quality assurance professional who has struggled with the MBR recognizes the opportunity for improvement. Share your thoughts and wishes. Maybe we can come up with some answers.