Batch Records

Batch records are finite records indicating the production and testing process for every batch, with identification of issues along the way. FDA Title 21, CFR 211.88 requires production records and electronic batch records (EBR) for each batch. Each EBR should include a copy of the corresponding master production and control record, along with the full history of batch production and control, including dates, signatures, and additional supporting actions. 

Electronic Batch Record

An Electronic Batch Record is a digital version of a batch record used to document every step of manufacturing in life science industries like pharmaceuticals, biotechnology, and medical devices. 

The main goal of EBRs is to digitally manage and document the production and quality control processes in manufacturing environments. EBRs help ensure that all documentation is accurate, complete, and compliant with regulatory requirements such as Good Manufacturing Practice (GMP), FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, and other relevant standards.

EBR will allow for easy tracking of the production of a batch, while capturing the following data elements:  

Production information,  

Materials used,  

Operator actions,  

Testing information,  

Deviations from production requirements, and  

Results.  

Each of these elements will be documented in a structured, time-stamped, and traceable manner. 

Generally, the electronic-based EBR will include the following sections to represent the electronic production and quality control information for a particular batch of product: batch identification, master batch reference, raw material usage, processing instructions, in-process controls, deviations, final yields, and audit trails, thus allowing for ease of retrieval and audit of the EBR. 

The regulatory requirements for EBRs have been addressed by a series of standards such as European Union Good Manufacturing Practice Annex 11, FDA 21 Code of Federal Regulations Parts 11 and 820, ISO 13485, and International Council for Harmonization Q10. Common elements of the regulatory requirements of the standards include data integrity, audit trails, user access controls, electronic signatures, and documentation of entire production lifecycle. 

EBRs are a secure, efficient, and compliant method of documenting batches for manufacturers. EBRs improve traceability and operational efficiency by replacing manual systems and creating an environment of quality, compliance, and continuous improvement for manufacturers today.  

Benefits of electronic batch records

Electronic batch records can save resources, especially time spent on mundane tasks, and boost efficiency by automating the management of batch records. It offers the following benefits: 

Improve consistency and accuracy: Humans are prone to bad days, attention lapses, and sleep deprivation that can affect what they write on paper. An electronic batch record system reviews user input in real-time and detects errors, which can minimize the possibility of mistyped, wrongly collected or incomplete data. 

Boost productivity: An EBR system removes error-prone and time-consuming data entry, allowing you to redirect human resources to other areas where creative decision-making can be useful. For example, employees can use the saved time to work on developing and maintaining SOPs. 

Save resources with Review by Exception: One of the features that an EBR system supports is review by exception functionality, an approach that cuts redundant review time. It highlights elements in the record that don’t comply with the specification. As a result, a batch record specialist or any other worker reviewing the record must review only the highlighted items. 

Standardize processes: You can use an EBR system to distribute the same batch of records to all operators. This verifies that all operators are working on the same version, even if they are based in different facilities. The standardization of workflow can reduce the risk of errors that occur due to operators working with obsolete data. 

Make data-driven decisions: Paper-based records store data in a disjointed manner. If someone from management wants to use this data to decide, it will take time to convert this data into a usable format. Due to these reasons, companies often make hurried decisions only based on data present at the moment. Such decisions fail to deliver sustainable results and lead to recurring issues.