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[e-drug] Climatic Zones of India - IVa or IVb? (4)

E-DRUG: Climatic Zones of India - IVa or IVb? (4)

Dear Colleagues,

The WHO Expert Committee on Specifications for Pharmaceutical
Preparations agreed in October 2006 to the revision of the current WHO
guidelines for stability testing of pharmaceutical products containing
well established drug substances in conventional dosage forms, published
in 1996 (Annex 5, WHO Technical Report Series, No. 863, 1996). The new
draft WHO document entitled "Stability testing of active pharmaceutical
ingredients and pharmaceutical products (QAS/06.179/Rev.1)" is based on
discussions held in the WHO Eastern Mediterranean Region and other
regional and inter-regional harmonization efforts. The aim is to achieve
a synergistic approach in developing a global text and to include the
stability test conditions adopted by the same WHO Expert Committee.

At the same meeting the WHO Committee noted the ongoing efforts of the
WHO Secretariat on the WHO stability guidelines and the recommendations
resulting from the discussions at the 12th International Conference of
Drug Regulatory  Authorities (ICDRA) on various aspects of stability
including the conditions for Zone IVa and IVb. The key recommendations

1. WHO Member States should identify their stability testing conditions in 
order to facilitate import to and export from their country. Ideally these 
should be based on conditions currently in use, thus avoiding creation of 
barriers to access to medicines.
2. WHO Member States should make information available to WHO regarding 
stability conditions to be used within their markets.
3. WHO should make available country information in order to facilitate 
accessibility by manufacturers and any interested party on an international 

In the light of the above it was suggested that the new WHO guidelines
on stability testing should include a comprehensive listing of WHO
Member States and their stability testing conditions. Efforts are
on-going to complete this list. To date the stability testing conditions
required by the Indian authorities have not yet been notified to WHO.
The revised draft text and listing will be scheduled for discussion at
next WHO Expert Committee on Specifications for Pharmaceutical
Preparations to be held later this year.

More information can be found on stability related issues at the
following web site:

With best regards,

Sabine Kopp

Dr Sabine Kopp
Quality Assurance Programme
Quality Assurance & Safety: Medicines
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Fax: +41 22 791 4730
WHO Medicines Quality Assurance website:

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