Consulting, Compliance and Validation

SPAI

New revision for Annex 1

Fourteen years in the making and two draft versions submitted in 2017 and 2020, on 25 August 2022 the final version of the new Annex 1 of the GMP (Good Manufacturing Practice) was published on the EudraLex website. Receiving over 6,000 comments[…]

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The most beautiful silence you’ve ever listened to

A few weeks ago, a world leader in the pharmaceutical packaging sector issued the official version of a digital product, namely a self-explanatory course intended for the foreign purchasers of a Primary packaging line. I was the appointed project manager of this digital product for technical training[…]

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Machines and workplace accidents

Deaths in the workplace were the subject of an episode of the Italian TV programme Report, which aired on channel Rai 3 on 9 May. While the European average is 2.2 deaths per 100,000 employees, Italy stands at 2.7, which is much[…]

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Fabio Farneti at COMtecnica events

A two-day, content-rich and professionally stimulating event with networking opportunities. COMtecnica Conference 2022, which was held a few days ago at the Ca’ Foscari University of Venice, was all that and more. Our company’s founder Fabio Giovanni Farneti also attended and spoke at the[…]

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Logbook: I’m investing in new offices

It has now been a year and a half since I wrote the last entry in my logbook and it is time to get back to writing again. I started this logbook during the COVID-19 pandemic as I wanted to understand what[…]

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Our Fabio Farneti to speak at the COMtecnica Conference

Our CEO Fabio Farneti will be speaking at the COMtecnica Conference, a two-day event to be held on 15 and 16 June 2022 in Venice (at Ca’ Foscari University), organised by COMtecnica SRL for COM&TEC Associazione Italiana per la Comunicazione Tecnica (the[…]

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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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