Consulting, Compliance and Validation

Pharmaceutical validation


Pharmaceutical validation

Considering the peculiar characteristics of the pharmaceutical industry, nowadays it is necessary to pursue an increasingly higher level of repeatability and safety throughout the production chain.

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Nowadays, just the ability of knowing and operating a system is no longer enough.


In order for pharmaceutical companies to be able to produce or package medicines, the competent authorities must issue an authorisation. The company can obtain the approval if it can be demonstrate that the production and packaging processes are carried out in accordance with GMP (Good Manufacturing Practice). The demonstration of the use of processes that follow these criteria is achieved through the Validation activity. Validation is a formal activity that follows the entire life cycle of the processes, considering  the machines, the structures, the methods, the utilities, the controls and in general everything that can cause a danger to the end user, namely the patient.

As the validation is a formal activity, it requires documented evidence of decisions taken and activities carried out. The documented evidence is made through the use of documents drawn up, verified and approved before the use by the personnel who hold responsibility in order to be able to declare their authenticity and usability.


Generally speaking, it is necessary to validate any aspect that may have an impact on  a patient safety, considering that this is compromised by the loss of integrity of the critical data recorded, by the lack and/or incorrectness of information relating to the use of the medicine and in general by any aspect that weighs on the physical, chemical and therapeutic attributes of the medicine.


The drugs are manufactured using manufacturing and packaging processes. Each process is defined by the following elements:

  • The drug is defined by its chemical formulation (active ingredients and excipients) and its quantity, and by its pharmaceutical form.
  • Packaging elements
  • Manufacturing processes
  • Packaging processes
  • Quality controls and their reaction
  • Utilities
  • Environments

The activities related to the drug can be multiple and for each of them have been defined and issued by the regulatory bodies of the directives that define good practices to be followed:

  • GMP (Good Manufacturing Practice) for the manufacture and packaging of the drug and its active principles;
  • GCP (Good Clinical Practice) for clinical activities
  • GLP (Good Laboratory Practice) for laboratory activities
  • GDP (Good Distribution Practice) for the distribution of the drug

All these rules are known as GxP.

In addition to the GxP defined by each country at the legislative level, there are the GAMP (Good Automatic Manufacturing Paratice) that unlike the previous ones are not mandatory but are a set of guidelines produced by ISPE recognized worldwide and currently considered the best reference point for the interpretation and application of the Laws in the drafting of documents and in all activities related to the Validation.

The validation of the machines follows their life cycle. In the contractual phase, the user (the pharmaceutical company) prepares the document URS (User Requirement Specification) in which it lists its needs, taking care to distinguish between the various aspects (quality, production, safety and maintenance).
The supplier should detail, through specification documents, how it intends to comply with the user’s requests. As quality is the aim of the validation, all parts of the system that have an impact must be detailed and explained in detail, also assessing the residual risk for any possible pharmaceutical defect.
Depending on the complexity of the system, the documents that can be produced are:

  • QPP (Quality and Project Plan)
  • Functional Specification (FS)
  • DS (Design Specification)
  • HDS (Hardware Design Specification)
  • SDS (Software Design Specification)
  • RA GMP (Risk Analysis GMP)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • PV (Process Validation)

Spai guides you through this complex regulatory and procedural framework to achieve the best performance in terms of quality and economy.

Why chooses us?

Because at Spai we are good, efficient, and professional .
Because thanks to validation model Spai “Quality Oriented”, the costs are limited.
Because the results of Spai have an high-quality standard.
Because at Spai, we adapt ourselves to the customer needs.
Because Spai offers itself as the sole interlocutor for a complete range of services.

Our mission

Our aim is to create and provide useful tools for the verification, disclosure, maintenance and archiving of information that is produced during the design and testing of automation systems