All pharmaceutical batches are utilized to document such items as raw material lots used, equipment utilized, temperatures, mixing times, operators, etc. These items are required to be tracked and documented for every pharmaceutical batch as part of the Code of Federal Regulations 21 part 188.
Generally, paper batch records have been utilized for pharmaceutical production. The issue with the utilization of paper batch records is the possibility of human error during documentation. Some of these human errors are production calculation, write overs, missing data, and missing initials and dates.
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The new and growing form of batch recording is Electronic Batch Record, also known as Manufacturing Execution System (MES). This form of batch record is not limited to just new production facilities. These electronic records could be limited to the maintenance department or to a single production line.
Many existing sites are moving to Electronic Batch Records for their robust capability to close out Lots. These systems will include the capability to communicate with installed equipment such as scales, autoclaves, SIP, CIP, COP, filling equipment, etc.
With these integrations, equipment calculation and system processes can be performed without the aid or involvement of human participation. This greatly removes the likelihood of human error and possibility of miscalculation of material addition, mixing time, temperature adjustment, etc.