The signpost for Quality Assurance and IT departments in pharmaceutical companies is “GAMP®5 Concept of Compliance of Computerized Systems with GxP Based on Risk Management“. This guide defines the best practices for ensuring compliance with GxP (GMP, GDP, GCP) regulations in the field of implementation and operation of computerized and automated systems, providing guidelines for consulting companies and suppliers of computerized systems in the Life Sciences sector.
Pharmaceutical production carried out as manual operations performed by employees is increasingly being replaced by automatic processes controlled by computerized and automated systems.
In practically every area of activity there is software that generates data used in the production, supply, storage or sale process.
In many areas it can be said that it is even difficult to meet a man – and the sight of “empty” warehouses or production halls filled only with working devices and flowing materials becomes normal. It can be said that more and more often it is not humans who produce – intelligent computerized systems do it.
New technologies bring great benefits in the form of greater efficiency, the possibility of improving the quality of products or even enabling the production of drugs that previously could not have been produced using traditional methods. There is, however, the other side of the coin. The complexity of new solutions, the interconnection of individual technical components (interfaces) and high operational requirements generate a high-quality risk.
In order to guarantee the highest security of the process of adapting new technologies to the requirements of the pharmaceutical industry, it is worth supporting yourself with good practices.
In order to minimize the risk of errors, various types of processes are implemented in pharmaceutical companies to re-check all dependencies and efficiency of mechanisms. These are, among others: functionality, process, data and authorization tests, user training and documentation, procedures, as well as the necessary reconstruction of functions.
Our trust in IT solutions grows in proportion to the technological development of systems, especially their reliability. They are becoming more and more effective, allowing to increase the pace of production and minimize mistakes. However, when human life is at stake, even the smallest details must not be forgotten. A computer program is made by a fallible man.
Therefore, it is worth providing tests, security and processes that will ensure that a defective drug will not be produced, and at the same time will ensure the possibility of its recall as soon as possible, if such a product does enter the market.
As you can see, people, programs, processes and procedures are standing on a pharmacy shelf behind each package of a medicine. It is difficult to break through errors through such safeguards. And scientists are constantly working to make it almost impossible.
The future of the pharmaceutical industry is clearly correlated with technological progress in the area of computerized and automated systems throughout the life cycle of a medical product. It begins in the phase of Research and Development, Clinical Trials, and ends with the sale of a medical product in a pharmacy, and even later, when data is collected on adverse effects or while the patient is being treated.
IT systems support both production, development and distribution, and the implemented technology includes such systems as ERP, LIMS, MES, SCADA, HVAC, BW, but also artificial intelligence systems or augmented reality are increasingly used.
Gerard Halski
Project Manager and Quality Manager at HICRON
For many years Gerard has been involved in the implementation and application of computerized systems in pharmaceutical companies.
Since 2009, a member of the ISPE association, actively involved in the work of the GAMP forum. Initiator of the GAMP®5 Step-by-Step training program and the first Polish edition of GAMP®5. From 2013, President of the Management Board of GAMP Polska. Member of the board of ISPE Polska since 2017.
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