Consulting, Compliance and Validation

SPAI

The cleaning validation process

The purpose of the cleaning validation is to verify that the cleaning procedures of a plant and of an equipment ensure that it does not occur a contamination. Cleaning validation is part of Annex 15 of the European GMP. Contaminations can be[…]

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Our offices will be closed for holidays from August the 9th to 13th

Our offices will be closed for holidays from August the 9th to 13th. We will be back on Monday, the 16th of August.

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Do you know the difference between a service and a product?

In these challenging times, I often stop to reflect on various aspects of my work. I have written about this in the Covid Diary, and now that there is a glimmer of light at the end of the tunnel, I want to[…]

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The journey of a pill

Is it possible to crush a pill and use it in powder form as an ingredient in a galenic medicine? Absolutely not, it would be a serious mistake that professional pharmacists carefully avoid.  Let’s use consider the following example. A patient, Mario,[…]

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Design review and remote progress of work

In every type of project, including the design and construction of automatic machines, activities of control and verification of work progress are carried out. These are moments in which information is acquired, opinions are exchanged, options are evaluated, possible setbacks are assessed[…]

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Checking the weight of pre-packaged products

Have you ever had the doubt that a product weighed less than what is stated on the label? Or have you tried to weigh a product (e.g. a cosmetic, as food products can have natural weight loss) and noticed that the weight[…]

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An unbelievably unthinkable year

An unbelievable year, or, it might better to say, an unbelievably unthinkable year. A new beginning has start, a beginning far different from the one of the past year but a new beginning, nonetheless. Vaccines will arrive and we will be travelling[…]

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COVID vaccine, why in Great Britain yes and in Europe still no?

In these days the pictures of the first citizens who have received the vaccine have been published; they are two British citizens (a woman from Northern Ireland and a man from England), who opened what it will be the biggest vaccination campaign[…]

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FAT testing and pandemic, how to safeguard everyone

In an article published a few months ago we talked about the difference between validation and testing. Testing can normally be divided into FAT (Factory Acceptance Test, tests performed before the equipment is sent to the customer) and SAT (Site Acceptance Test,[…]

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Anti-Covid vaccine: caution is needed

The news that the pharmaceutical company Pfizer (in collaboration with Biontech) would have almost ended, with excellent results, the phase 3 of the COVID-19 vaccine tests, has brought euphoria not only in the financial markets but also among Governments, mass media and[…]

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