Consulting, Compliance and Validation

SPAI

GMP in the pharmaceutical sector: How to detect defects – Part Two

In the first part of our journey through the potential defects that can occur in the production and packaging of drugs, we focused on critical data printed on the packaging and defects in the drug itself. Today we will discuss the other[…]

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GMP in the pharmaceutical sector: How to detect defects – Part 1

GMP (Good Manufacturing Practices) in the pharmaceutical sector refers to the set of rules, procedures and guidelines according to which the production and packaging of drugs must be organised to ensure product quality, the safety of the end patient and the integrity[…]

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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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