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

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

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

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

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

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

Examples of Comments received and to be considered

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

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

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).

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.