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Events and news

Blog

Polymeric materials in manufacturing processes: a new theat...

In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic...

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Interview with Paulino Alonso: ICHQ3D on Elemental impurities...

ICHQ3D implementation involves a risk analysis to design strategies to control elemental impurities in drugs for human use,...

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Webinar on ICHQ3D (Elemental Impurities)

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in the human medicines. Deadline...

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Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a...

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Key aspects in the implementation of directive ICH Q3D

ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines. But there...

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What are the Occupational Exposure Limits and why are they important?...

Chemical substances are being increasingly used in different sectors, including the pharmaceutical one. Thousands of these...

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How to Identify extractables and leachables Impurities

The packaging materials for pharmaceutical products are designed to protect them from environmental contamination. However,...

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Environmental Risk Assessment. ERA reports

The environmental risk assessment process for a medicinal product is complex. It is based on overall usage, destination...

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Phases in the evaluation of the occupational exposure to a chemical...

The aim of the hazard assessment is to determine the classification and labelling of the substance and to establish the...

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Polymeric materials in manufacturing processes: a new theat...

The range of polymeric materials available in the industry is very broad and materials have been developed with very different...

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Organic impurities: ICH Q3A AND ICH Q3B

Identification and quantification of impurities in active ingredients and drugs products is a crucial aspect in pharmaceutical...

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Toxicological assesments using (quantitative) structure-activity...

When assessing pharmacological and toxicological profile of chemical structures, several approaches are possible, including...

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Key factors for the implementation of directive ICH and Q3D...

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PDE calculation in shared facilities for veterinary medicaments...

On June 2016 will be coming into effect for veterinary medicaments EMA’s guideline (EMA/CHMP/CVMP/SWP/169430/2012) already...

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Phases in the evaluation of the occupational exposure to chemical...

After the banding control has been established along with the strategies to be followed, it is necessary to carry out a...

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Extractable and Leachable Impurities Regulation

The loss of quality of the medication due to the presence of extractables and leachables added to the risk that these impurities...

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Extractable and Leachable Impurities

Depending on their chemical nature and migratory properties from the container to the medium, these types of organic or...

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RESIDUAL SOLVENTS IMPURITIES. ICH Q3C

Solvents used in pharmaceutical industry are generally volatile organic compounds that are involved in many processes of...

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Mutagenic impurities assessment following ICH M7 guideline

Mutagenic impurities assessment following ICH M7 guideline comprises impurities identification and classification, followed...

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Phases in the evaluation of the occupational exposure to a chemical...

After calculating the OEL and categorising the substance, the Occupational Exposure Band (OEB) must be obtained that will...

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Toxicological evaluation of impurities in pesticides

Use of pesticides is a key factor in control agricultural and food pests and to pest vector control, especially in epidemics....

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What is ICH Q3D on elemental impurities?

Directive ICH Q3D aims to limit the presence of potentially toxic elemental impurities (also known as heavy metals) in pharmaceutical...

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4 key points for a better understanding of ICH Q3D approach

Our experience with the implementation of ICH Q3D has showed that the new approach is not always well-understood by suppliers,...

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Identification and quantification of impurities: a crucial aspect...

Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient...

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