**10. Why QRA is worthy?**

QRA provides us with a systematic and deep knowledge of the problems faced by the process under study. In this sense QRA can help us to overcome one of the main troubles derived of the application of GMP, their being seen as a kind of "tables of the law". The consideration of GMP as the golden principles supposed to provide the answer for every problem, has often led to a passive attitude. We had a problem and then we looked up in GMP. Now, QRA means that we analyze and understand well our problem. It is not necessary to say that this is extremely important and worthy.

Quality Risk Analysis: Value for Money in the Pharmaceutical Industry 407

Prepare flow-charts

Perform PHA

Identify operations

*Auditor / Inspector*

Objective: Convince herself / himself that the quality of the products is ensured

Course of action: Verify that hazards and their causes have been identified and that control measures are in place

Measures: Verify that procedures (SOPs) exist, that they are appropriate and that personnel has been trained

Results: It has been verified that hazards are controlled and that the quality of the products is ensured

**Figure 14.** The documentation virtuous circle

Find control measures

Continual improvement

**Write procedures**

our hazards and we keep them mastered.

*Pharmaceutical company*

Objective: Ensure the quality of the products

Course of action: Identify the hazards and their causes and implement control measures

Measures: Write procedures (SOPs) and train people

Results: Hazards are controlled and the quality of the products is ensured

**Figure 15.** How to face an inspection/audit

Inspections and audits worry always personnel. They remind them of the student days and consequently they ask themselves again "how can I pass them successfully"? In the school the obvious answer would have been "learn well the lessons of the program", but in the pharmaceutical industry the program is less obvious and "lessons" are not so clearly stated. They have to take into account GMP, of course, but also other things (GLP, regulations, guidelines, unwritten expectations, company standards, etc.). Here again QRA can help us. As summarized in the figure below our approach should focus in showing that we know

Identify hazards

Identify processes

**11.2. Inspections / Audits** 

QRA is also a key element in the introduction of improvement in the pharmaceutical industry. Without the concept of QRA, improvement would not be understood. In the past improvement didn't exist, because we didn't accept risk. Now when we recognize risk and accept that it is inevitable we can also say that improvement exists and that it consists of the reduction of this risk.
