Pharmaceutical validation

PHARMACEUTICAL VALIDATION

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.

WHAT IS IT NECESSARY TO VALIDATE?

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 PRODUCTION AND PACKAGING PROCESS

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

GxP
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:

All these rules are known as GxP.

GAMP
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.

VALIDATION OF PRODUCTION AND PACKAGING MACHINES
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: