Consulting, Compliance and Validation

If validation becomes faster and easier, the advantage for the pharmaceutical company is considerable

The long time required for compulsory ministerial validation is a handicap for the pharmaceutical industry, which needs to introduce quickly its product into the market. On the other hand, properly performed validation is necessary to guarantee the integrity and safety of the drug to the consumer, as well as to protect the company from the risk of withdrawal of the product, with consequent image and economic damage. SPAI, a Bologna-based company specialised in technical information for industry, has achieved a goal of reducing the time required for the validation process, making it even more effective, in over 10 years of studies and experience in the field, with over 4,000 validation activities and several hundreds of risk analyses. “We have been involved in risk analysis since it was not mandatory – explains Fabio Farneti, SPAI administrator – and for this reason we have spent many years studying analytical methods with the aim of developing a rapid and effective process. We adopted the Fta (Fault tree analysis) method and applied it to the analysis system, creating a dedicated software, for our exclusive use, that allows us to speed up and make the analysis homogeneous”.

What do you mean by ‘homogenising the analysis’?

“I mean that, with the same starting elements and answers obtained, the result is the same, regardless of who carries out the analysis. Our procedure eliminates any randomness that can be derived from the human factor, i.e. the professional who performs the risk analysis”.

Are there other reasons why you think it would be useful to adopt your method of pharmaceutical validation?

“Our method entails time savings and a documentation that is more usable and easier to manage. We have always worked with the system based on the Fmeca method (Failure mode, effects and critically analisys), which is traditionally still widely used, but we believe that our validation strategy is more advanced, functional and convenient because it reaches the heart of the problem in a direct way”.

What are the characteristics of your method?

“Our approach is a deductive one, starting with the problem, identifying the cause and assessing it. To simplify, the question could be: what danger do we want to avoid? What are the causes that generate it? What solutions have been adopted to limit them? What is the residual risk? In doing so, we go back to the process, defining the possible criticalities and how to deal with them. We have identified and inserted in our system the complete spectrum of problems to be avoided and we have coded every possible cause, which we then cross with the design of the machine examined to identify potential critical points during the production process and the packaging of the drug“.

While the most commonly used method?

“The logic of the inductive method is antithetical to that proposed by us and involves a greater amount of work, with obvious repercussions on the timing of production. Without taking into account that over time the machinery changes, there are components that are added, others that are eliminated … and this involves every time the problem of updating, something made more complicated by documentation really difficult to manage. In the inductive method, the process is first divided into blocks, which in turn are divided into other blocks and so on until you get to the individual brick. At that point the question arises: if this brick fails, what happens? To give an answer you need to recombine the structure to see the effect of that malfunction on the higher levels. The difficulty of managing an anomaly, with consequent extension of the production stop, derives from this complexity”.

The time factor seems to be decisive for you…

“It is decisive for our client. Time is essential to ensure that the pharmaceutical company is competitive in the market. Let’s assume we speak about a new product. From the marketing request to the commissioning of the production line, a certain amount of time passes; this time is necessary for all the studies and the internal steps within the company, which result is a purchase order to the supplier. The supplier will have to design and build the machine trying to deliver it in the shortest time. In this time, also the validation has to be carried out, which is required by the Ministry of Health. Therefore the method has to be streamlined but effective, like ours. This can make a real difference.”