Masterstudiengang "Drug Regulatory Affairs"


Global Requirements for Stability Testing - Are they Realistic for All Climatic Zones? –A Critical Evaluation ***

Dr. Michael Klimars (Abschlußjahr: 2005)

Language: English
This master-thesis deals with the consideration whether global requirements for stability testing are realistic. Therefore after a short explanation of the aim of stability testing the concept of the four climatic zones assigning each country in the world to one of the four zones is presented.

The conditions and regulatory requirements of Climatic Zones II and IV are introduced and in this connection also the adaptation of intermediate Climatic Zone II storage condition to long-term Climatic Zone IV storage condition.

This master-thesis gives information on primary packaging and stability problems of active substances and drug products arising from different storage conditions in different climatic zones.

The difference between measured mean arithmetic temperature and calculated mean kinetic temperature is explained. The conception of humidity as a degradation energy (enthalpy) for active substances or medicinal products susceptible to moisture is demonstrated as well as the conception of absolute humidity as driving force of degradation processes.

Common primary packaging materials and their suitability for liquid and solid dosage forms in moisture permeable containers are presented and the conception of permeation (diffusion) of water vapour through permeable primary packaging materials is discussed.

ASEAN countries` concerns as to reduction of relative humidity in long-term stability testing according to ICH guideline and different approaches justifying different storage conditions for long-term stability testing conditions, especially for Climatic Zone IV are being discussed.
Finally this master-thesis ends up with a discussion of advantages and disadvantages of a global uniform stability testing of active substances, respectively medicinal products.

Pages: 35