**2.1. Product**

388 Risk Management – Current Issues and Challenges

QRM is and use it in the right way.

**Figure 1.** Hazard – Risk - Harm

The potential source of harm

company who have to take a decision.

**2. Knowledge is the base of everything** 

*achieve an objective.* 

has been devoted to it.

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.* 

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

The importance of quality risk management (QRM) is such that a whole ICH guideline, Q9,

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

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).

QRM is a powerful machine but to move has to be filled with a kind of fuel called "knowledge". If we don't know anything about our product or process, we cannot manage risk. Risk, by definition, is the combination of the probability and severity of a hazard. And if we don't

This explains why knowledge management is put beside QRM as an enabler. Experience shows that more often than not information on the products and on the processes is "lost", either because it is not duly registered and disappears or because it is just kept away by a given person and never diffused within the company. The result is that in many cases there is or there was information but it is not available when needed by the persons of the

Damage to health, including the damage that can occur from loss of product quality or availability.

And the fact is that if we cannot gather information on the product or process, either in house or outside it (other sites, publications, courses, etc.) it is very unlikely that we might follow a QRM approach. In other words, both enablers are linked and thus, the amount and

know the hazards, not to say their likelihood and importance, there is no way for QRM.

**Hazard Risk Harm** 

The combination of the probability of occurrence of harm and the severity of that harm.

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



And this can only be achieved by people possessing or gathering this knowledge and analyzing it subsequently by means of brainstorming. A table like the following one can be helpful in performing this.

Quality Risk Analysis: Value for Money in the Pharmaceutical Industry 391

Error Maybe Scales will be provided with

**Preventive measures** (what could we do to control or mitigate this problem?)

a printer

monitoring system for filled vials

controls each box

Yes Qualify filler and organize a

No A weighing machine

**Preventive measures** (what could we do to control or mitigate this problem?)

Dedicated HVAC system without recycling

Containment of the product by negative differential pressure surrounded by positive differential pressure

Ensure adequate training

Introduce isolators where product is exposed

**Likeness** (is that likely to happen?)

**Process stage** 

**Problems** (Deviations from the normal situation?)

starting material

#8 Lack of leaflet Leaflet fell outside

#1 Wrong weight of

#3 Irregular dosage of vials because dose is very low

**Table 2.** Table for process brainstorming

The elements likely to influence them;

configuration

Pressure differentials

**Attributes Sub-attributes Influence** (which role

Personnel Training High risk of error /

In this case brainstorming can be facilitated by:

Inquiring regulatory authorities.

the constitution of this situation / element). Ask people about their experience on this.

Reviewing technical literature and attending congresses.

Our needs / requirements.

Premises HVAC

**2.3. Comparison** 

**Causes** (what might provoke this problem?)

Filler has not enough capacity

the box

And finally, if we are comparing two different situations, then we should identify:

they may play?)

Risk of crosscontamination

Protection of the environment

confusion

products

Note: The contents of this table are just given as an example; they don't intend to represent any real situation.

Carefully analyzing the attributes and sub-attributes (e.g., the factors which intervene in

Protection Manipulation of active

**Table 3.** Table for comparing two different situations / elements

Their characteristics (their main attributes and sub-attributes);

Note: The contents of this table are just given as an example; they don't intend to represent any real situation.


Note: The contents of this table are just given as an example; they don't intend to represent any real situation.

**Table 1.** Table for product brainstorming

Several approaches have been proposed to facilitate this brainstorming, such as,

