News

Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

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Swissmedic resumes Inspections

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.

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EU: Checklist for Brexit Preparation

The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK.

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European GDP Association nominates new Board Member

The European GDP Association, representing more than 2,200 professionals from across the globe, has extended its Board. Emil Schwan was invited to join the Board and accepted his nomination.

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GDP Monograph for Active Substances: Interactive PDF now available

The "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published recently as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. An interactive PDF of the document is now accessible free of charge in the member's area of the European GDP Association.

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New Post in the MHRA Inspectorate Blog on Quality Risk Management in GDP

Quality Risk Management (QRM) is a fundamental requirement in the Good Distribution Practice (GDP) environment. It is applicable to a variety of activities and processes, such as temperature mapping studies, supplier qualification, deviations, and change control. In this context, a new post, entitled "A Practical example of applying Quality Risk Management in GDP - Transportation Risks", has been published in the MHRA Inspectorate blog.

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The Responsible Person: What are the Key Elements which should be covered a Job Description?

The EU-GDP Guidelines require that wholesale distributors have to appoint a responsible person (RP) for GDP. A written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. But what are the elements which should be covered in such a job description?

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Distant Assessment leads to GMP Non-Compliance Report

The Austrian competent authority has published a Statement of Non-Compliance with GMP to an Austrian manufacturer after a distance assessment. The Manufacturing Authorisation was now revoked.

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New GDP Monograph for Active Substances published

The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute.

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Pharmaceutical Associations underline Importance of MRA with UK

Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.

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