Weighing Data Integrity: 3 Ways To Ensure Compliance

By Doug Dodridge

Weighing – though sometimes oversimplified or neglected – is an important process step in pharmaceutical manufacturing. Dispensing raw materials, dosing material into a tablet coater, checking granulation or tableting all require weighing and documentation for complete, compliant batch records. As such, Good Documentation Principles apply to these activities as stated in relevant Good Manufacturing Practice (GMP) guidelines.

Humans are capable of error, even when stakes are high. At the same time, pressure on production costs means resources need to be spent wisely. While paper logs have historically been the norm and tend to be low-cost, automation of results capture and storage can help reduce error risk, enhance productivity and reduce waste or rework for more accurate, compliant processes.

Automating all or a part of data gathering with electronic solutions can help make sure documentation is accurate, traceable and stored safely. In this paper, we will compare manual transcription to documentation with three automated or partially automated solutions, assessing the pros and cons of each.