# Cybernetic Model Design for the Qualification of Pharmaceutical Facilities
## 1 Introduction
The purpose of the \"V\" model was to create a solid basis for testing the functionality of the system against some original design specifications and to prove that the technical solution produces the desired results. The \"V\" model, shown in (Figure 1), although seemingly applicable everywhere, is, nevertheless, too general. It refers to the qualification of equipment, systems, processes, computerized systems, as well as certain verifications. Little can be concluded from it, and the requirements of the regulatory authorities would not be satisfied with the application of such a generalized model. However, the model defined in this way represents the basis for the possibility of developing new models for the qualification of pharmaceutical plants. Standard ASTM E2500 [8] has several similarities with the traditional V-model process; however, the recommended tests no longer follow a rigid FAT/SAT/IQ/OQ/PQ sequence  
Figure 1: Initial “V” model for qualification [7]. as described in EU GMP Annex 15. They are now brought together under the single term \"Verification\" and can be more rationally organized and efficiently adapted to each context. A similar approach was applied during the creation of the model, which will be shown in this paper. Referring to the recommendations of the FDA, it is stated that the validation of the pharmaceutical process is the most important and recognized parameter of GMP. Quality assurance techniques must be used to build quality into the product at every step and cannot just be tested in the end. This paper shows the steps for the qualification of plants in general but, throughout the entire research, it emphasizes the importance of all stages of qualification. It also demonstrates the correct representation of documentation management through validation and qualification processes [9]. The validation life cycle is shown in Figure 2.  
A very interesting and detailed study was published in 2006 by [PERSON] in his doctoral dissertation: \"The Validation of Pharmaceutical Buildings\" [10]. Based on the observation of participants in the field, during qualification activities, on three construction projects, as well as by using an industrial questionnaire, he constructed a model for the qualification of pharmaceutical facilities--Figure 3. Through research, he proved that validation activities in many cases do not meet the goals constructed by the created model. With his study, he made a significant breakthrough in the given period, as he studied an insufficiently researched area, which led to a better understanding of the qualification process. Additionally, by researching the industry, which included the views of the pharmaceuticals and contractors, he concluded that there is a big gap and different definitions of quality, as well as the terms \"qualification\" and \"compliance with requirements\". This is still the case today. The study highlighted that there is a general lack of understanding and communication between the pharmaceutical industry and contractors. Throughout the research, it became clear that construction project managers probably tend to understand quality as a measure of workmanship, while pharmaceutical project managers view it as safety and regulatory compliance. Figure 2: Validation life cycle [9]. The term \"quality\", the most stressed word in the pharmaceutical industry, is extremely difficult to define, especially since its definition and application are formulated differently in the construction (contractors) and pharmaceutical industries. Fifteen (15) years later, based on the research presented in this paper, there is still a lack of understanding and communication between contractors and pharmaceutical companies. In the section Research Methodology, we present the basis for such conclusions and define proposed solutions to overcome the mentioned problems.