How a pharmaceutical validation ‘should’ be carried out
In the last meeting with our Sole Administrator Fabio Giovanni Farneti, we talked about the difference between validation and testing in the pharmaceutical sector, leaving us with this question: “If in a validation, differently from a test, only the parts related to[…]
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Validation and testing in the pharmaceutical sector: what is the difference?
In the course of our long experience we often noticed that there is confusion between the concept of validation and testing: the are often considered as the same thing and it is believed that the testing can substitute the validation process. Let[…]
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The instruction manual as a safety factor
We talked about the history of the instruction manual, the rules that govern it and the procedures that we at Spai follow for its drafting. In this article we want to explain that the instruction manual should not be seen as a[…]
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How to write the instruction manual
After briefly telling the story of the instruction manual, or rather, how the evolution of the world of work, after the Industrial Revolution, has led us up to the recent legislation on work, in this article we talk about how to draft[…]
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Brief history of the instruction manual
È It is with the approval of the so-called Machinery Directive of 1989 that, for the first time, the responsibilities of the employer are linked with those of the manufacturer who makes the working tools. It was at this time that instruction[…]
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A new site for Spai
To ensure our customers the highest quality in our services and consultancy at Spai we continuously invest in specialized human resources, professional updates and technologies. Today we are pleased to announce the opening of a second site of 260 square meters, in[…]
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The safety of a medicine
The safety of a medicine derives from a long and complex chain that starts from the research phase and arrives at the moment in which the patient or the paramedic open the package and manage the substance to be taken. Throughout this[…]
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Risk analysis, is it time for a change of mentality?
In Europe, the development of risk analysis in the pharmaceutical sector took its first steps in 1998, as an appendix to the Gamp (Good automated manufacturing practice) guidelines. The fifth revision of the Gamp guidelines clearly states that “the application of quality[…]
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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[…]
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Help4Tech: how it works
This is the second part of the Help4Tech article, the new assisted maintenance service activated by Spai Srl. Read the first part of the article. The use and maintenance manual is not always consulted by who works on the machine and it[…]
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