GMP Trends and Analyses!

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

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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Questions and Answers to Cloud Computing in a GxP Environment - Part 3

Questions and Answers to Cloud Computing in a GxP Environment - Part 3

Nine experts from the pharmaceutical industry and regulatory authorities answer frequently asked questions on cloud computing. Please read more here

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Self-Inspections

Self-Inspections

An excerpt from the new ECA Code of Practice for GMP Auditors. Please read more here

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Continuous Tableting and the Road to Global Adoption

Continuous Tableting and the Road to Global Adoption

This article sketches the long road of the development of continuous tabletting to its adoption by the industry as well as regulatory bodies and looks to possibilities for the future. Please read more here

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The GMP Update 2023/2024

The GMP Update 2023/2024

2023 saw a lot of new developments in the GMP environment. This article summarizes a few selected highlights. Please read more here

 

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