GMP:Blog

10.06.2025 | LOGFILE Feature 12/2025

Water Qualities – Water for Injection (WFI)

5 min. reading time | by Fritz Röder

Production and use

The European Pharmacopoeia defines Water for Injections as water that is intended for use in the manufacture of medicines for parenteral administration whose solvent is water (WFI in bulk), or water that is used to dissolve or dilute substances or preparations for parenteral administration (sterilised WFI). An overview of its potential uses is shown in Figure 1.

09.06.2025 | QUESTION OF THE WEEK

What is a validation test?

06.06.2025 | NEWS

EU: Council Agrees on Position for the 'Pharma Package'

The European Council has adopted its negotiating position on the major reform of EU pharmaceutical laws, the 'Pharma Package', and is now ready to start talks with the European Parliament.

06.06.2025 | NEWS

FDA: Launch of “Elsa” AI Tool

The U.S. Food and Drug Administration (FDA) has launched Elsa, a generative AI tool aimed at enhancing the productivity of its employees, from scientists to investigators.

27.05.2025 | LOGFILE Feature 11/2025

AI in the GMP Environment: What do the Regulators Expect?

5 min. reading time | by Azade Pütz

Introduction

The rapid development and increasing use of Artificial Intelligence (AI) in the pharmaceutical industry requires a clear regulatory framework to ensure safety, quality, and trustworthiness. In this complex environment, the EU AI Act, relevant ISO standards, and the EMA's reflection paper on the use of AI in the life cycle of medicines play a central role in shaping the regulatory landscape. These instruments aim to find a balanced approach that promotes innovation while minimising potential risks.

26.05.2025 | QUESTION OF THE WEEK

What do the abbreviations VP and VR mean?

20.01.2025 | AUTHOR

Our Authors

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!

02.01.2025 | AUTHOR

Dr. Birte Scharf

Birte Scharf, PhD, is a pharmacist and works as a Senior Scientist in the GMP Compliance Team at Franz Ziel GmbH.

20.03.2023 | ASK OUR EXPERTS

Ask our Experts

As a subscriber ot the GMP Compliance Adviser, you can ask the editorial team questions at any time. Of course, this is also possible with free demo access.

Do you know? The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business!

The demo access ends automatically.

>>> Test it now for free

10.06.2025 | LOGFILE Feature 12/2025

Water Qualities – Water for Injection (WFI)

5 min. reading time | by Fritz Röder

Production and use

06.06.2025 | NEWS

EU: Council Agrees on Position for the 'Pharma Package'

The European Council has adopted its negotiating position on the major reform of EU pharmaceutical laws, the 'Pharma Package', and is now ready to start talks with the European Parliament.

27.05.2025 | LOGFILE Feature 11/2025

AI in the GMP Environment: What do the Regulators Expect?

5 min. reading time | by Azade Pütz

Introduction

20.01.2025 | AUTHOR

Our Authors

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!

20.03.2023 | ASK OUR EXPERTS

Ask our Experts

As a subscriber ot the GMP Compliance Adviser, you can ask the editorial team questions at any time. Of course, this is also possible with free demo access.

Do you know? The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business!

The demo access ends automatically.

>>> Test it now for free

09.06.2025 | QUESTION OF THE WEEK

What is a validation test?

06.06.2025 | NEWS

FDA: Launch of “Elsa” AI Tool

The U.S. Food and Drug Administration (FDA) has launched Elsa, a generative AI tool aimed at enhancing the productivity of its employees, from scientists to investigators.

26.05.2025 | QUESTION OF THE WEEK

What do the abbreviations VP and VR mean?

02.01.2025 | AUTHOR

Dr. Birte Scharf

Birte Scharf, PhD, is a pharmacist and works as a Senior Scientist in the GMP Compliance Team at Franz Ziel GmbH.

Production and use

What is a validation test?

Introduction

What do the abbreviations VP and VR mean?

Production and use

Introduction

What is a validation test?

What do the abbreviations VP and VR mean?

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