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PQ (Performance qualification) and the difference with process validation
The PQ (Performance Qualification) tests the functionality of the machine under standard production conditions. It is the first qualification phase in which the machine is tested “in process”, with the focus on the product and not just the equipment. PQ is part[…]
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Validation procedures: COM&TEC course, spokesman Fabio Farneti, SPAI Ceo
The training and refresher course “Validation procedures. Analysis, drafting, management”, organised by COM&TEC (Italian Association for Technical Communication), which will have as its speaker Fabio Giovanni Farneti, CEO Spai, will take place online on 25th March and 1st April 2022. The aim[…]
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Italy seeks industrial autonomy in the health sector
The Ministry of Economic Development has published a notice for Italian companies to submit projects in the health sector. The notice, which is part of the IPCEI (Important Project of Common European Interest), has a deadline of 28 February 2022 and aims[…]
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IQ OQ PQ validation
When we talk about IQ OQ PQ we mean the process of qualifying an automated machine: how it is composed, its operational processes and the performance achieved. The qualification of the equipment is part of the pharmaceutical validation process, which is the[…]
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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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