# An Adequate Pharmaceutical Quality System for Personalized Preparation
## 3 A Review of the Evolution of Quality Management Systems for Medicines
### Elaborated Quality
\begin{table}
\begin{tabular}{p{113.8 pt} p{113.8 pt} p{113.8 pt}} \hline \hline  & **Industrially Manufactured Medicines** & **Personalized Preparations** \\ \hline Batch size & Large batches & Mostly as a unit product (a medicine/prescription). Small batches, only in official formulas. \\ \hline Variability in product/laboratory & A limited number of different medicines/items in each laboratory. Patients adapt to the medicine. The homogeneity of all medicines with the same item number is guaranteed. & Great diversity in medicines; heterogeneity. As many prescriptions as there are patients: subject to changes in pharmaceutical forms and active ingredients; combinations and modification of dosage, excipients, packaging, etc. Great versatility and extensive knowledge are required to be able to pursue development and compounding in a limited timeframe. The medicine is tailored to the patient [16]. \\ \hline Investment of resources in each medicine & Each development entails validations and controls, and significant investment of time, money, and personnel. The mean time invested to receive authorization to market a medicine is about 10-12 years with a financial outlay of approximately 800 million Euros [28]. After scaling, production yield is high. & Limited resources and minimal time (from prescription to dispensing: hours or days) are available to design and develop a wide range of medicines. Without these time and resource limitations, it would be unfeasible to be able to respond to the personalized creation of such products at a price that was not exorbitant. As stated in the European resolution on quality assurance and safety requirements for medicines prepared in pharmacies (personalized preparations), the risks of a delay in the supply of a medicine to treat the patient must be assessed, albeit without ignoring the possible risk that could result from an error in preparation. The production is at times singular, making sampling impossible and quality control destructive. \\ \hline Supplies/quantities of raw materials and medicines & The portions of initial, intermediate, and final products are large and it is produced in batches. The yield achieved with high-quantity production makes it possible to invest effort in continuous improvement and process knowledge. & Very small quantities are handled, both in terms of starting materials, in the quantities weighed, and in the number of preparations that are repeated after each design. Handling small quantities involves difficulties. For example, weighing is common to all manufacturing processes, but weighing small quantities generates greater error. (There is a link between the weighed quantity, the sensitivity of the scales, and the error made in this basic operation). \\ \hline Profitability & The initial investment of time and resources to develop a new medicine is high, but once it moves to an industrial scale, the investment is profitable through the high yields achieved with industrial equipment and processes. & For each prescription: development includes a search for information, design, development, specific documentation, purchase of materials from suitable suppliers, validation by creating a production protocol, and lastly, preparation of the final compounding. This is often done for a once-off prescription. As for raw materials acquisition in cases of single preparations, it should be discarded without being used because suppliers do not have small enough sizes. \\ \hline \hline \end{tabular}
\end{table} 
Table 2: Differential aspects of industrially manufactured medicines and personalized preparations.