GMP:Blog

25.04.2025 | NEWS

WHO: New Technical Report (TRS 1060) published

The WHO has released a series of new and updated guidelines related to pharmaceutical manufacturing, testing, and development, published as part of Technical Report Series No. 1060 (TRS 1060). Annexes 2 through 9 address a range of topics, including nitrosamine control, GMP for excipients, bioanalytical methods and blood establishments.

21.04.2025 | NEWS

ICH: Revised ICH Q1 Draft for Consultation

The International Council for Harmonisation (ICH) released an updated draft of its Q1 guideline on "Stability Testing of Drug Substances and Drug Products". The ICH Q1 draft guideline reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period. A Step 2 Informational Presentation has also been developed by the Q1 EWG.

15.04.2025 | LOGFILE Feature 08/2025

Good Storage and Distribution Practice: What is the WHO GSDP Guideline about?

3 min. reading time | by Petra Rempe, PhD

In its GSDP Guideline published in 2020, the WHO summarizes current requirements for the storage and transport of medical products and at the same time attempts to harmonize international requirements. This guideline also contains an annex with recommended temperature and humidity limit values for storage and therefore also transportation temperatures.

Read a short summary of the guideline below.

14.04.2025 | QUESTION OF THE WEEK

How can QRM be used?

01.04.2025 | LOGFILE Feature 07/2025

Water Qualities – Drinking Water as Source Water

6 min. reading time | by Fritz Röder

Pharmaceutical water occupies a unique position in the pharmaceutical industry. Raw materials and excipients are normally only used after quality control and subsequent release. Pharmaceutical water, however, is always used immediately after it has been produced because microbiological approval can take several days. For this reason, pharmaceutical water is regarded as being extremely critical, and there are many specifications in the pharmacopoeias and GMP regulations.

31.03.2025 | QUESTION OF THE WEEK

How do we deal with risks?

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

25.04.2025 | NEWS

WHO: New Technical Report (TRS 1060) published

15.04.2025 | LOGFILE Feature 08/2025

Good Storage and Distribution Practice: What is the WHO GSDP Guideline about?

Read a short summary of the guideline below.

01.04.2025 | LOGFILE Feature 07/2025

Water Qualities – Drinking Water as Source Water

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

21.04.2025 | NEWS