**11.2. Inspections / Audits**

406 Risk Management – Current Issues and Challenges

reduction of this risk.

**11.1. Documentation** 

grouped.

their contents.

operations.

necessary to say that this is extremely important and worthy.

**11. Some common problems solved by using QRA** 

inspections/audits and handling of active products.

basically related to logistics, organization and personnel.

GMP. Now, QRA means that we analyze and understand well our problem. It is not

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

QRA is a powerful instrument, which may help to solve typical problems faced by the technicians working in a pharmaceutical laboratory and in this sense the ICH Q9 guideline provides many examples regarding the potential applications of QRA "in [4]". It is however worthwhile to study in detail three very common problems: documentation,

"Which documents do I need?" or "tell me which documents I have to prepare and I will do it" are much heard questions. And this is so because GMP does not provide an answer. An impossible answer, anyway, because documentation is closely related to every particular situation and this is why GMP just mentions the documents directly associated with the products (specifications, formulae, processing instructions, etc.) and some general documents (sampling, testing, release, etc.). Documents have to be established on a case by case base, even if in the end all laboratories finish by having about the same documents and the basic difference relies on their extension and on how information is organized and

Documentation is used to attain two basic goals, information on how to perform operations, in general, and confidence in the control of critical operations, in particular. The first determines basically the number of documents to be written, whereas the second focuses on

Write a list of the processes of your company and then prepare flow charts for each of them. By doing this a number of operations will appear. Procedures have to describe these operations. There is no rule of thumb about how many are needed. Neither very long nor very short procedures are practical. Consequently a certain level of grouping is necessary and each company has to decide how to do it. Factors which might help in this decision are

Once you have these flow charts perform on them QRA using a very basic tool such as PHA. This will allow detecting hazards and will oblige thinking of the related control measures. And then, these control measures will have to appear in the documents describing the 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 our hazards and we keep them mastered.

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