A batch record is a mandatory GMP document in which every factor and action impacting the manufacturing process is noted, including materials, time, operators, equipment, etc., to ensure compliance, safety, and quality in production. According to FDA, managing or controlling batch records is required not only in drug manufacturers but also in dietary supplements and other bio-products.
Most drug makers in Vietnam are familiar with using paper batch records—hard copy documents that workers and operators fill out following GMP principles or site requirements. However, paper batch records have many drawbacks due to manual implementation:
- Lack of data and information: This is the most common error that leads to blanks in batch records due to the subjective of workers. As a result, the needed information is not filled out, such as time, signature, etc.
- If the format of BR is designed illogically or used by newly trained staff, it is easily lead to incorrect execution, missed steps in granulations, or missed frequencies of IPC tests.
- Incorrect data entry: Although data can be retrieved or traced, it can cause errors.
- Delay in troubleshooting: Problems or events are usually detected during the review BR quality officers; therefore, damage may affect many manufacturing stages. The reprocessing, rework, or CAPA are also accompanied by a series of other procedures.
- Some other errors such as: the printed profile is missing or blurred, torn or wet leading to data loss, etc.
These inconveniences resulted in the need to conduct tracking and data investigations; seriously, in some cases, freezing and destroying the entire batch is possible.
Besides, records reviews require lots of effort and time from quality assurance officers and experts, resulting in a longer release time but still not guaranteeing precision in the process of assessing the batch records.