Data management in the pharmaceutical industry
Operators of pharmaceutical production facilities are constantly facing great challenges. You can optimally meet the demands for productivity, quality and resource efficiency if your experience is supported by an ideal source of decision-relevant information. There are numerous potential savings to be made in the many different areas of work.
But how do companies find real opportunities along the complex production chain? Information systems such as TeBIS® from Steinhaus help to raise individual potentials in the pharmaceutical industry.
According to Wikipedia 2006, 117,000 people are working in the pharmaceutical industry. In this wide field, valid information is very important to make quick and correct decisions. With our information systems we provide the pharmaceutical industry with a clear competitive advantage.
An information system can usefully supplement the existing IT infrastructure in the pharmaceutical industry in the following ways:
- Document the production according to regulations such as GMP. ALCOA or FDA 21 /CFR part 11
- Increase productivity
- Analyse processes
- Increase capacity utilization
- Optimize machine use
- Increase the efficiency of facilities and machines
- Document valid key figures
- Prove a constant or improved product quality
- Saving resources
- Use energies and synergies more efficiently
and much more.
Whether energy, human resources, technology or raw materials: an intelligent process data management system such as TeBIS® can help you to raise hidden potentials for more performance and resource efficiency by including all relevant process variables. TeBIS® also provides you with a reliable tool for improvement in terms of efficient energy management.
Pharmaceutical production and its potentials
Working with TeBIS® demonstrates: The processes of the pharmaceutical industry generally have a high potential density. In most cases, pure substances are not used to produce medications, but preparations of medicinal substances and excipients, thus producing finished pharmaceuticals. Although the pharmaceutical industry in Germany is already highly technical, there are more possibilities for savings in this part of the process - above all in the recycling of raw materials and the cleaning of machines and equipment.
Special aspects of the production of pharmaceuticals
Medicines, like food, are physically consumed by humans. Therefore, manufacturers are required to be particularly reliable in terms of hygiene (sterility) and product homogeneity (dose of ingredient). Therefore, the pharmaceutical industry has developed methods and procedures which ensure the correct implementation of the procedures and their tamper-proof documentation. The non-changeable data archives of TeBIS®- A, in combination with the storage of the logical process image as well as the separate handling and tracking of manual corrections, are an ideal basis for providing this proof in accordance with GMP, ALCOA+, FDA 21 CFR Part 11 or similar regulations.
Development of pharmaceuticals
In non-clinical development, new ingredients are identified, improved and tested for their suitability as pharmaceuticals in specific experimental-pharmacological test systems. Significant savings can often be made here without missing important steps.
With intelligent systems, savings potential can be identified in most companies in the pharmaceutical industry. At the management level of a pharmaceutical company, an individual analysis is particularly advantageous. The condition for all findings is the precise and targeted recording of process-relevant data and the evaluation of the data in appropriate information systems. Based on these steps, savings potentials in the range of five to ten percent can be realized without much effort, as a study in the chemical industry has shown.