The approach of Spai to pharmaceutical validation



Fabio Farneti is the owner of Spai srl, an Italian consulting, compliance and validation company. After exploring the difference between testing and validation, in this conversation he helps us to understand the features of the validation model proposed by his company.

Partial doesn’t mean superficial

Unlike what happens during testing, in the validation process are tested only those parts of the equipment parts that affect the final product’s quality. That means a smaller number of tests for validation rather than for testing. So, how can we be sure that we considered everything and didn’t forget anything of importance?

First of all, Farneti explains that the aims of testing and validation are not the same, so it’s normal that the activities are different too. Testing is performed by the equipment’s supplier, with the aim of verifying that the performances comply with the client’s requests. The responsibility of validation, instead, belongs to the client. Its purpose is to ascertain that the product processed with the equipment is safe for the patient, as well as that data integrity is observed.

The validation is now a complex activity composed of several steps. One of them involves the identification of the equipment’s parts that are crucial for the safety of the process and that will consequently undergo validation. How can we start such a complex activity? Usually, with a document named URS (User Requirement Specification).

From URS to validation

The URS is a document written by the pharmaceutical company that buys the equipment. It aims to provide the specifications that will drive the choice of the supplier and the purchase of the equipment. But the document has also another purpose, as Farneti explains. As a matter of fact, it provides a list of critical GMP points on which the validation will focus.

The evaluation of the GMP impact of the new equipment is then carried out before the purchase and even before the choice of the supplier. However, the GMP section of the URS is only the starting point of the process. In this document are listed both the critical points and the faults that the client wants to avoid, but not the technical solutions adopted to reduce the risk of those problems. As a matter of fact, this last information should be given by the supplier. He has the knowhow to suggest technical solutions to handle the equipment in order to avoid undesired situations and to prevent faults. Sometimes a client can have enough knowledge to find solutions to the equipment’s problem, but maybe he’s not as up to date as the supplier can be. Technology is in continuous evolution and the solutions get old very quickly. Ultimately Farneti observes that everyone should do his own job: the user manufacture medicines, the supplier produce and fix equipment.

The power and the difficulties of DQ

The Design Qualification (DQ) is latest news in validation, that’s why Farneti chooses to describe the importance of this step, sometimes misunderstood by the companies. DQ aims to verify the compliance of the equipment to the client’s project and URS. It’s the step in which are really identified the validation tests to perform.

This is a powerful tool, but its implementation isn’t as easy as the other validation steps are. IQ, OQ and PQ, indeed, are managed by the client, who usually creates a document containing procedures for each step and uses it to perform some activities to test the equipment. The DQ requires instead that the supplier shows to have understood the URS’ GMP critical points, having analyzed its own equipment looking for the parts involved in those points, defined the residual risks, and found the solutions to avoid them. It’s clear that such a step is more complex than the previous one. There are then some documents that help the supplier to collect and submit all the necessary information. Farneti lists, for example, the GMP Risk Analysis document, that is needed to evaluate the risks involved in each critical equipment parts. Different specification documents based on the complexity of the system are used to collect all the solutions adopted. Furthermore, the link between URS, risks analysis and specification documents should be clarified through the Traceability Matrix (TM), a table where each specification is linked to the step of the validation in which it will be tested.

TM: the core of validation

The supplier should send these four documents to the client for approval. The bouncing of the documents between final user and supplier can continue for more than once, because the information can be collected over time, especially for the TM. This document benefits from the synergy between client and supplier, and it needs time to be improved. The result is a living and discussed document, built with the help of both parts. The TM can then be defined as the very core of validation. Each point of the matrix is indeed to verify: that’s the way we select, identify and motivate the verifications.

The right answers come from right questions. To be sure we have verified everything we needed, it’s important to have clear in mind why we are verifying.

Fabio Farneti


This is the validation process, and that’s the way to do it right. But, in Farneti opinion, unfortunately, the theory is often far from the practice and the best practices of validation aren’t always adopted by suppliers and pharmaceutical companies yet.


Spai srl, based in Bologna, Italy, is a validation, compliance and consulting company founded in 1998. It has more than twenty years’ experience in packaging and pharma industry, focusing specifically on validation, managing of technical information, assisted maintenance, consulting and training. Spai already works with pharma suppliers, and now it addresses directly the pharma industry to propose a new approach to pharmaceutical validation.