Tips for Successful EBR Projects

Although few manufacturers doubt the ability of electronic batch records (EBRs) to move mountains of paperwork, some have had their faith in the technology severely shaken. This occurs mostly when their goal has been only to convert an existing paper-based system into an electronic version, according to Reddy Beeram, director of product development at Edgewater Fullscope, an enterprise resource planning (ERP) consulting firm.

As worthy a goal as going paperless can be, Beeram considers the following considerations to be important success factors for EBR projects:

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Streamline the production process. “Standard operating procedure for a paper-based batch record is vastly different than one that would be applicable to an electronic batch record,” explains Beeram. “When you’re collecting data manually on paper, logging information can happen at any stage of the process, as long as no downstream dependencies exist.” In the case of EBRs, however, information logging must occur at specific times for the process to advance to the next step.

Embed streamline quality reviews. “Embedding quality checks and automation into the process should minimize the amount of time that regulatory departments have to spend on reviewing the batch record information,” says Beeram.

Adopt a “right the first time” philosophy. A proper implementation of an EBR would have embedded validations and workflows that reinforce work instructions.

Develop interfaces for all associated systems. “EBR implementation is not limited to the production process within the ERP system,” notes Beeram. “There are multiple systems that feed information to the ERP from a batch record standpoint, like MESs [manufacturing execution systems] and LIMSs [laboratory information management systems].” When designing and implementing an EBR solution, consider that all systems can affect the batch record as a whole.

All About Electronic Batch Record

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.