**4. Structure of a pharmaceutical quality system (PQS)**

The paradigm of quality described by the ICH guidelines, Q8 to Q12 [1, 2–5], should also be applied to pharmaceutical projects, but taking into account the existing differences between manufacturing and managing a project. This is why not all the elements of a quality system devised for products can be applied into a pharmaceutical project. Let us analyze this (**Figure 1**).

The development and implementation of a PQS is the result of the definition of a quality policy by a laboratory. In order to put this policy into practice, the company writes a quality manual and associated documents that develop it in more detail. A quality manual should address the following topics:


**Figure 1.** *Structure of the PQS (ICH Q10).*

or processes do not inform the others, but keep it for them and, consequently, there is a continual loss of information.

4.The PQS contains four elements (**Figure 1**). All of them, albeit not in this form, are very important in a project.
