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GMP Publishing Embarks on a new Digital Chapter

GMP Publishing Embarks on a new Digital Chapter

After months of intensive work, creative ideas, and technical finesse, the time has finally come: the GMP Verlag website has been given a fresh new look. With a clear structure, fresh design, and optimized user-friendliness. 

This allows GMP-Verlag to make its expertise in GMP even more accessible and tangible. 

You are already right in the middle of it. Discover the world of GMP!

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

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EMA: Concept Paper on the Revision of Annex 15

EMA: Concept Paper on the Revision of Annex 15

EMA and PIC/S have published a concept paper outlining a targeted revision of Annex 15 (Qualification and Validation).

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What do Typical Manufacturing Processes for Sterile Products look like?

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Human Resource Management as a Key to Success

Human Resource Management as a Key to Success

The pharmaceutical industry in Germany and other countries, too, faces considerable challenges in the area of human resource management. These problems have far-reaching implications for the competitiveness and innovative power of the industry.

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EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

The EMA has published a new reflection paper outlining its current thinking on the qualification of non-mutagenic impurities (NMIs). The paper addresses recommended approaches for evaluating the safety of new or increased impurity levels, particularly when such impurities exceed the ICH Q3A/Q3B qualification thresholds and are identified after completion of non-clinical toxicology studies.

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EMA: Discussions on the Revised ERA Guideline

EMA: Discussions on the Revised ERA Guideline

During the second industry stakeholder webinar on the revised guideline on environmental risk assessment (ERA) for medicinal products for human use, the European Medicines Agency (EMA) addressed key implementation challenges observed during the first year of application.
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EMA: New Q&A on Product Lifecycle Management (PLCM)

EMA: New Q&A on Product Lifecycle Management (PLCM)

The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.
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