While human error is never the ultimate root cause, mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections.
In more serious cases, when the error is initially undetected, the consequence can be a product recall. Errors can be minimized through the implementation of electronic batch records.
However, with any electronic batch record system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. These essential requirements need to be included in the initial design phase of the system.
cGMP Factors For Successful Electronic Batch Records
A central part of cGMP concerns electronic data management, not least because control of the use of batch records when manufacturing pharmaceutical and biotechnology products are regulated to assure product quality and patient safety. cGMP in relation to electronic records includes:
- limiting system access to authorized individuals
- use of operational system checks
- use of authority checks
- use of device checks
- the determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
- establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
- appropriate controls over systems documentation
These requirements need to also be considered for all electronic records, with specific attention to electronic batch records. The electronic batch record uses the certified copy of the Master Batch Record in the form of a digital document with a digital signature.