# An Adequate Pharmaceutical Quality System for Personalized Preparation
## 4 ICH Objectives for a Pharmaceutical Quality System
### Application of the Objectives to Personalized Preparations  
When reviewing the possibility of compliance with the quality objectives set by ICH in regard to personalized preparations, it can be seen that:  
1. The main guarantees for fulfilling objective one in the case of a personalized preparation are scientific knowledge and good practices of the prescribing professional and the pharmacist who makes and dispenses the preparation. These professionals take full responsibility for the quality of the preparation process and the use of the medicine [35]. 2. The quality management system applied in the compounding laboratories from the acquisition of the initial materials to the controls and the dispensing of the product ensures that products with the right quality are made, as described in the legislation. In Spain, RD 175/2001 brought about a change in this regard, since it regulates the rules of proper preparation and quality control of magistral formulas and official formulas. In fact, customer satisfaction with personalized preparations is high [36; 37; 38]. In addition, satisfaction is very high since this is a medication that is designed, prescribed, and developed for a specific patient to treat a particular pathology. These reasons also make it possible to reduce side effects [39]. Compliance with the first objective is thus ensured. * Meanwhile, from a quality control perspective, an intrinsic limitation based on the very personalized nature of the preparation has already been described in previous sections: the impossibility of measuring certain attributes that define quality. * The second objective is partly fulfilled in the case of personalized preparations since some controls can be instituted that offer information about the process and the quality of the product, though there are certain limitations. Process monitoring strategies can be established using protocols that are the result of compound production validations and detailed knowledge of manufacturing operations. There are restrictions at this point: unitary and heterogeneous production means that the possibility of monitoring by means of certain quality controls is reduced. * Quality risk management will make it possible to identify what is important and what is not, meaning that resources can be usefully applied, thereby obtaining the best possible results. The products and their processes must be fully known and understood and must be analysed to identify any real hazards and risks. Once the risk is known, it should be assessed and accepted or rejected depending on its level and the ways in which the risk may be reduced or avoided [27]. * Detailed knowledge of the product and process management of a personalized preparation is sometimes limited by the resources available for its development and restricted by the variability and time limitations noted elsewhere. Even so, as [PERSON] states [3], the authorities agree that the risk associated with the development of personalized preparations is considered acceptable given their added value, even if they are not prepared under the same quality system as at the industrial level. * In terms of complying with the third objective, when improvements are identified during the magistral formulas compounding process, they are implemented and incorporated into the work protocols. Restrictions are again observed in the detection of such improvements in relation to the previously mentioned peculiarities of personalized preparations. The limitation of not being able to perform certain controls that provide information about processes can be restrictive when identifying areas for improvement. A need for improvement may be found, though the exact processes affected might not be identified if they are not all monitored. Proposal of a Strategy for Overall Improvement in the Personalized Preparation Quality System: Proficiency Testing  
This article has thus far shown that there are certain shortcomings in the quality system for personalized preparations.