GMP Trends and Analyses!

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

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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The FDA Warning Letter Report 2023

The FDA Warning Letter Report 2023

The analysis of the FDA warning letters for fiscal year 2023 has a surprise in store. Please read more here

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Quality Standards for Medical Cannabis - Update on Pharmacopoeial Monographs

Quality Standards for Medical Cannabis - Update on Pharmacopoeial Monographs

Currently there is a growing interest in the use of medical Cannabis in the global healthcare sector. Thus, comprehensive quality standards and regulatory measures for these natural substances are needed. Please read more here.

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Are Data Quality and ALCOA attributes equivalent?

Are Data Quality and ALCOA attributes equivalent?

The attributes utilized to evaluate the integrity of data and records associated with activities covered by the medicines’ manufacturing practices applicable regulation in the life sciences sector is called ALCOA. It is relevant in other areas, particularly pharmaceutical research, clinical, testing, and the supply chain. Please read more here.

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FDA 483s and Warning Letters concerning Stability Testing

FDA 483s and Warning Letters concerning Stability Testing

Stability tests are designed to determine how a drug product or active ingredient changes under certain conditions - temperature, humidity, exposure to light - during a specified period of time. Please read more here.

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