GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

Pharmaceutical contracts and their importance for the Qualified Person

Pharmaceutical contracts and their importance for the Qualified Person

Pharmaceutical contracts are of great importance not only for the delimitation of general and specific contractual issues in the working relationship. Please read more here

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Use of Artificial Intelligence in the 100% Visual Inspection of Parenterals

Use of Artificial Intelligence in the 100% Visual Inspection of Parenterals

Artificial intelligence and machine learning have the potential to change patient care in the healthcare sector. Please read more here

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GMP Hot Spots as seen in the Warning Letters - Stability Testing

GMP Hot Spots as seen in the Warning Letters - Stability Testing

Stability tests on finished medicinal products and their components, active ingredients and excipients, are an essential part of GMP-compliant manufacturing. Please read more here

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Audit trail in EU GMP Annex 11 and EMA Concept Paper on Annex 11

Audit trail in EU GMP Annex 11 and EMA Concept Paper on Annex 11

Every change to an entry in a document should be signed and dated. Despite the change, the original information should remain legible. Please read more here

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Development of modern pharmaceuticals, vaccines and more

Development of modern pharmaceuticals, vaccines and more

Part 1: Advanced Therapy Medicinal Products (ATMPs) - cell and gene therapies. Please read more here

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CTR Implementation - A QP's Perspective

CTR Implementation - A QP's Perspective

On 31 January 2025, the transition from the Clinical Trial Directive 2001/20/EC (CTD) to the Clinical Trial Regulation (EU) No 536/2014 (CTR) will end. Read more about the consequences for Qualified Persons (QPs)

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Conference report on the ECA GMP & GDP Forum (Part 2)

Conference report on the ECA GMP & GDP Forum (Part 2)

June 20 - 22, 2023 in Barcelona - Day 3: GDP. Please read more here

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Conference report on the ECA GMP & GDP Forum

Conference report on the ECA GMP & GDP Forum

June 20 - 22, 2023 in Barcelona - Day 1 and 2. Please read more here

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