1. Session 7: VICH Conference
Development of VICH Guidance on Stability Studies To Address Climatic Zones III and IV
Dr A T Sigobodhla
Session 7: VICH Conference
Tokyo, Japan: 27 – 29 October 2015

2. Introduction Background Conclusion Problem statement Current situation
PRESENTATION OUTLINE
Introduction
Background
Problem statement
Current situation
Work done, comments and glimpse of the OIE survey
Conclusion

3. Introduction: Purpose of stability testing
To provide evidence on how quality of the Active Pharmaceutical Ingredient (API) or Final Product (FP) varies under the influence of:
a. Temperature
b. Relative humidity
c. Light/moisture (if applicable)
2. Establish a re-test period for the API or shelf life for the FP
Stability chambers

4. Background Topic proposed: IFAH-Europe in 2010
Problem statement: current VICH GL 3 on stability addresses requirements for climatic zones I and II only
Implications:
No “common” document or common consensus addressing requirements for climatic zones III & IV
Differences in testing conditions between countries in the same zone

5. Progress made since November 2013
29th VICH SC Meeting : recommended that more work was required before SC can make a decision
Task Force was formed
1st half of 2014: OIE Survey: Collected information from OIE member countries on their current stability testing conditions and their willingness to contribute to this amendment
Task Force considered comments received
Expert Working Group was formed

6. Mandate of the Expert Working Group
Recommendations at the 31st VICH SC meeting:
Quality EWG to continue with the work initiated by TF and seek good representation of experts from VOF regions with active involvement from Asia, Africa and Latin America
EWG to develop a basic guidance that is a stand alone document not a revision of current GL3
Keep new guideline simple, with a stepwise approach for further development
It was hoped that South Africa and Australia could contribute to the work

7. Examples of Comments received and to be considered

8. Benefits
Eliminate current discrepancies within the zones: harmonisation of testing conditions mandatory
The Proposed stand alone Guidance on stability studies for climatic zones III and IV, in conjunction with VICH GL3 (R) will be a single source for VICH and non-VICH countries alike
Clarity and predictability on technical requirements for stability testing in climatic zones III/IV – no additional studies and specific negotiations needed
Increased product availability
Solid, scientifically based criteria readily usable for evaluation by regulatory agencies

9. Long-term Testing Conditions
WHO climatic zones
Climatic zone
Definition
Criteria
Mean annual temperature measured in the open air/ Mean annual partial water vapour pressure
Long-term Testing Conditions I
Temperate climate
≤ 15 °C / ≤ 11 hPa
21 °C / 45% RH II
Subtropical & Mediterranean climate
> 15 to 22 °C / > 11 to 18 hPa
25 °C / 60% RH
III
Hot and dry climate
> 22 °C / ≤ 15 hPa
30 °C / 35% RH
IVA
Hot and humid climate
> 22 °C / > 15 to 27 hPa
30 °C / 65% RH
IVB
Hot and very humid climate
> 22 °C / > 27 hPa
30 °C / 75% RH

10. Application of WHO GL to Animal Health?
1. Climatic zones
Require clear definitions, incl. scientific criteria to be applied for stability evaluation
Important differences between Animal and Human health with regards to dosage forms (impact of packaging on moisture (non-)uptake)
Duration of long-term stability data for regulatory submission (VICH 6 months vs. WHO 12 months)
Lack of harmonisation of WHO GL within regions
Consider in particular, the impact that the GL could have on the shelf life of products in other climatic zones (Zone I and II).

11. Conclusion
The SC reviewed the results of the OIE Survey regarding potential acceptance of a VICH guideline on stability testing for climatic zones III and IV and noted;
many of the respondents with relevant climatic zones indicated a willingness to use such a VICH guideline and many respondents are prepared to provide input into the VICH activity.
sufficient assurance was provided that a VICH guideline considering stability for climatic zones III and IV would be used by non-VICH countries.