Skip to main content Skip to search Skip to main navigation

WHO publishes Technical Report Series No. 1025, 2020

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in form of Annexes.

With the publication of the 54th Technical Report Series No. 1025 of the WHO, several new and revised Guidelines were adopted and recommended for use.

 

In the area of „Quality Assurance – GMP” these are:

  • Production of water for injection by means other than distillation (Annex 3)
    The Expert Committee noted that the document should be integrated into WHO’s existing guideline on Water for pharmaceutical use.
  • Good chromatography practices (Annex 4)
  • Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance (Annex 6)

In the area „Quality Assurance – distribution and supply chain“ the following two documents were adopted:

  • Good storage and distribution practices for medical products (Annex 7)
  • Points to consider for setting the remaining shelf-life medical products upon delivery (Annex 8)

Clicking here takes you directly to TRS 1025, that summarises and interprets all results of the 54th WHO-Expert-Meeting of October 2019 in Geneva. The final guidelines are listed in form of annexes and will be published on the WHO website as single documents shortly.


Source:

WHO: Specifications for Pharmaceutical Preparations

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

The US FDA has issued a new draft guidance (April 2026) on Impurity Specifications for Antibiotics.
Read more
EDQM: Guidance on Traceability of Medicines in Hospitals

EDQM: Guidance on Traceability of Medicines in Hospitals

The EDQM has published new guidance on the traceability of medicines in hospital settings. The aim is to improve traceability up to the point of administration and strengthen patient safety.
Read more
Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

At the GMP-PharmaCongress in Wiesbaden, GMP inspector Frank Sielaff (Regional Authority in Darmstadt, Germany) shared practical insights from recent inspections, high-lighting deficiencies in CCS implementation.

Read more
Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Here's the answer:
Read more
EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

In their „Horizon Scanning Report“, EMA and HMA have recommended updates to the regulatory framework to keep pace with developments in radiopharmaceuticals. Due to their unique characteristics these products require specific regulatory and scientific approaches.
Read more
GMP Meets Radiation Protection – How Do They Fit Together?

GMP Meets Radiation Protection – How Do They Fit Together?

The manufacture of radiopharmaceuticals requires simultaneous compliance with the EU GMP Guide and radiation protection regulations, which can lead to conflicting objectives between product safety and personal protection. Technical solutions such as negative pressure systems and lead-lined cells, as well as early consultation with the authorities, are crucial for implementation that complies with both GMP and radiation protection requirements.
Read more
Previous
Next