Remote audits in clinical investigation Learning from the COVID-19 pandemic

by Telstar

The COVID-19 pandemic has led us to consider the work schemes used so far and reflect on tools that can help us continue to fulfil our obligations and routines safely, such as remote audits, which are...

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How to read supplement labels

by Natac Group

Reading supplement labels can be challenging and scary at times if you don’t know what the numbers mean for you and your health

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En proceso de elaboración nueva norma ISO/TS 22421:2021 de esterilizadores hospitalarios by @ISOstandards @normasUNE

by Tecno-med Ingenieros

Aunque tenemos diversas normas de procesos de esterilización que regulan los métodos de esterilización de productos sanitarios que van a ser utilizados estériles esta claro que van orientados al f...

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BREXIT – La @MHRAdevices actualiza los requisitos UK para los productos sanitarios a partir de 1 de Enero de 2021

by Tecno-med Ingenieros

La Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido (MHRA) ha publicado una nota informativa de los requisitos para comercializar productos sanitarios en UK desde 1 de Enero d...

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Assessment of a pharmaceutical laboratory to meet the requirements of the new Annex 1

by Telstar

As a result of the changes introduced by EU GMP Annex 1 on the Manufacture of Sterile Medicines and despite the fact that it has not yet been finally approved as of today, some pharmaceutical laborato...

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Filtración Esterilizante y Aspectos Regulatorios – Jueves, 17/9 – Online Training by 3M & Asphalion

by Asphalion

Los procesos de validación esterilizante son críticos en la industria farmacéutica, con fuertes regulaciones internacionales y estricto cumplimiento de GMP’s.

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Improving business Quality

by MICROPTIC S.L.

With the goal of customer satisfaction, Microptic is very committed to Quality. Both from the point of view of the distributor or the end customer, and from the point of view of compliance with legal ...

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Maximize the Value of Formulation Data

by CAS, a division of the American Chemical Society

Formulators touch almost every aspect of our daily lives by responding to consumer demands and bringing creative innovations to market. Formulating represents a crucial step in the product development...

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Telstar Consultancy service helps pharma laboratories to comply with the new guidelines of EU GMP Annex I

by Telstar

The new Annex 1 sets the new standards of good manufacturing practices on sterile medicines production

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Nitrosamines Risk Assessment – Deadlines & Updates

by Asphalion

In both 2018 and 2019 the presence of N-nitrosamines was found in sartans with a tetrazole ring but it was also detected in other API/medicinal products (e.g. in some batches of pioglitazone and ranit...

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Register now for the Advanced FDA Regulatory Affairs online training course by LS Academy!

by Asphalion

The Advanced FDA Regulatory Affairs online training course will take place on the 4th and 5th of November, 2020 and it will provide you with an insight into the required information on how to set up y...

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Informe Rapex 1r Trimestre 2020

by Gabinete Técnico Farmacéutico M Camps

En el 1r Trimestre de 2020, las alertas publicadas mediante el Sistema Rapex de alertas para consumidores de la UE han retirado retirado 634 artículos que no cumplían con las normativas de seguridad...

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