**1. Introduction**

Pharmaceuticals play an important role in keeping people fit, but they can also put live at risk if they don't have the required quality. Contamination and mix-up may have a great impact on them because of their tiny active doses and because of the often precarious state of health of the patients, not to mention the existence of routes of administration, which skip certain defense barriers of the body.

To cope with this problem "Good Manufacturing Practice" (GMP) was introduced in the 1960s with the intention of providing a kind of common quality baseline for all laboratories. GMP, however, consists of general rules, and as such, it can neither give an answer to every practical situation, nor replace the need to study and understand processes in depth, as some people wanted to believe.

This is why the American FDA initiative on GMP, launched in 2002, underlined the need of taking decisions based on knowledge and science "in [1]".

The ICH (International conference on harmonization of technical requirements for the registration of pharmaceuticals for human use) has given world-wide diffusion to this initiative and put it into practice by publishing several closely related Q (quality) guidelines "in [2-5]".

These guidelines have to be applied conjointly in order to ensure that the quality of a product is, first of all, developed and, then, monitored within a quality management system. This pharmaceutical quality system, as defined by ICH guideline Q10, has two "enablers": knowledge management and quality risk management.

Knowledge management is defined as *a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components*.

© 2012 Botet, licensee InTech. This is an open access chapter distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2012 Botet, licensee InTech. This is a paper distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Whereas, quality risk management is described as *a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle.* 

Quality Risk Analysis: Value for Money in the Pharmaceutical Industry 389

**Quality risk analysis (QRA)** 

Write a report

Follow-up

**Quality risk management (QRM)** 

characteristics of the knowledge at our disposal will be one of the main factors which will

Revise the analysis

QRM is the result of a certain number of operations or steps, which can be summarized in different ways differing only slightly one from the other. The first part of QRM is evidently devoted to the quality risk analysis (QRA), that is, to *the estimation of the risk associated with the identified hazards*, whereas the second one concerns, properly speaking, the administration of this risk. Any QRM process has to start by defining its goal (what is

**Rejected Accepted** 

Draw consequences

But, speaking in practical terms, what kind of knowledge we need? Let us try to respond to

 Its CQAs (critical quality attributes), that is *physical, chemical, biological or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to* 

intended) and by gathering information. All other steps are shaped by this first one.

dictate how to perform our QRM.

Define objectives and gather information

Define the procedure

Modify as necessary

Perform the analysis

**Figure 2.** Quality risk management steps

**2.1. Product** 

this question by considering three different cases.

*ensure the desired product quality* "in [4]".

Its characteristics and specifications

If we are dealing with a product, we might need to be familiar with:

They are called enablers because they constitute *a tool or process which provides the means to achieve an objective.* 

The importance of quality risk management (QRM) is such that a whole ICH guideline, Q9, has been devoted to it.

Thus, QRM combined with GMP and science is a kind of "magical potion", which we can use to become "wizards" ensuring quality. However, this is only true if we understand what QRM is and use it in the right way.

Unfortunately practice shows that the real role of QRM is not always understood and as it has already happened in the recent past (e.g., with validation) it can become something that is only done, because it is required by the Authorities, but that it does not yield what it might and is just written for the occasion, shown and filed. And this is not something unimportant because resources which are misused here become resources that lack there…

Let us then review some key points for making the most of quality risk management (QRM).
