**3. GMP and QRM**

An interesting question that might arise as a consequence of the application of QRM is about precedence. What is more important a GMP statement or the result of a QRA? This is however a completely false question because if GMP can be considered the logic baseline in pharmaceutical production, then how can QRA be anything different?

Quality Risk Analysis: Value for Money in the Pharmaceutical Industry 393

**Flowchart / Process map / Checklist/ Ishikawa diagram**

**FMEA** (Failure Mode Effects

**FMECA** (Failure Mode, Effects and

**HACCP** (Hazard Analysis and Critical Control Points)

**HAZOP** (Hazard Operability

**Control charts / Design of experiments / Histograms / Pareto charts / Process capability analysis**

(fishbone), etc.

estimated **PRA** (Preliminary Risk Analysis)

Analysis)

Analysis)

problems **FTA** (Fault Tree Analysis)

estimated **PHA** (Preliminary Hazard Analysis)

Criticality Analysis)

According to their function QRM tools can be classified in three main groups: risk analysis,

Risk analysis tools are either inductive or deductive. The first, starting with the normal operation, try to detect possible problems. The second, starting with the problem, try to find the chain of events that led to it. It is also very common to talk about formal and informal tools. In fact the former have really been devised for this purpose, whereas the latter are just

It might seem surprising to explain that there are QRM tools that do not consider risk, but hazard. Although this is discussed in more detail below, here we need only point out that "risk analysis or management" is a general concept which can consider just hazards or their

**Characteristics Tools**

Evaluation and monitoring of

Analysis of deviations by means

Identification of real or potential

Even if it is true that specific tools have been developed with an intended objective, and this somewhat restricts their scope of use, there is often overseen that they can have a wider utility. In fact tools are at our service and we should use them to organize information in order to get the most of it. Except in those cases when there is a need for coordination, e. g., different sites of the same group, or a requirement by the Authorities we should feel free in

**Tools for risk comparison Risk Ranking and Filtering**

Identification of hazards and their potential effects

Evaluation of failure modes and of their potential effects

of "key words"

hazard

Simple organization of data

Risk is not

Risk is not estimated

Risk is

Risk is estimated

data given in a certain way and they can be only considered "tools" in a loose sense.

risk comparison and statistical support.

associated risk too.

Inductive / single factors

Deductiv e / multiple factors

**Table 4.** Basic classification of tools used in QRM

In practice, it is possible to distinguish six basic cases in QRM:

**Supporting statistical tools**

the way we use QRM tools.

Basic / Informal

Formal

**Tools for risk analysis**

**Figure 3.** Problem management

In fact QRM is complementary to GMP because it provides the frame for taking a decision, whereas GMP proposes us some practical and well known solutions. It is important to understand that "good manufacturing practice" has been, and still is, accompanied by some amount of "bad practice". And this is the result of seeing in GMP as a kind of oracle which will provide us with magical solutions.

No solution for a problem should be looked for, before having defined it perfectly. This assertion might seem surprising but experience shows that analysis is often left aside because all attention is eagerly focused on the quick search of a solution.

Once the problem is well understood and its causes and likely effects have been determined is when the search for a solution can be started. In any case this requires, as said before, possessing knowledge. It is evident that GMP has to be taken into account, but only when the problem has been analyzed and understood in depth. Then, an answer to the problem can be found and it is evident that it will be science and knowledge-based and GMP compliant.
