Data Management in Herbal Medicinal Products Manufacturing Processes: Documentation, Batch Processing Record and Electronic Data Management

Abstract

Good Manufacturing Practice (GMP) is part of quality assurance which ensures that products are consistently produced and controlled to the intended quality standard with aim to diminish the risks, probably occurring in any pharmaceutical manufacturing. There are worldwide different GMP for herbal medicinal products, has been issued revised and implemented as guidelines or regulatory statement, each depending on the perceived values in health maintenance and improvement. Documentation is an essential part of quality assurance system and the key operating in compliance with GMP requirements with the main objective to establish, control, monitor and record all activities, impacting on all aspect of the quality of medicinal products. Batch Processing Records (BPR) is an important and a useful type of record for medicinal products manufacturing documentation, as the lower level of Hierarchical documentation system which the most specific and the largest amount of data these documents in this level support. It is possible that the facility maintains all the operating data strictly as paper records however manually finding a large data to be analyzed or calculated will require excessive time and human effort. To be leveraging the speed and effective of data management afforded by computer, reducing the effort tasks with only keystroke and mouse click. There are additional things to be concerning when the electronic data management has been designed to use: appropriated electronic tools selection; generating of standard operating practice for using electronic data management tools; staff’s training; and maintaining the condition and quality of the tools. In case of herbal medicinal products manufacturing, electronic data management which corresponding to standards and other related regulation needs to be done.