Stability data must demonstrate stability of the medicinal product throughout its intended shelf‐life under the climatic conditions prevalent in the target countries. Light . stability studies conducted for countries ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Now our concern is “QUALITY guideline”, in that stability guidelines. The stability studies of pharmaceutical products are one of the very important parameter for development of new drugs as well as new formulations. Our forced degradation studies encompass stress testing under acid or alkaline conditions, oxidative stress testing and photostability studies. We offer a variety of studies that may be important to your product submission, including transit excursion studies and in use studies. Product Stability Testing and Storage Eurofins BioPharma Product Testing provides secure storage and experienced testing of your samples according to your specified procedures and timetables. Stability data must demonstrate stability of the medicinal product throughout its intended shelf‐life under the climatic conditions prevalent in the target countries. stability studies conducted for countries Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures. Ultra low – used mainly for storage of Biological samples eg. ICH – Q1F - Stability Data Package for Registration in Climatic Zones III & IV Stability Study Long Term Accelerated Condition 30±2°C / 65±5% RH 40±2°C / 75±5% Data Required 12 months 6 months Stress Condition: 50°C at ambient humidity to cover extremely hot & dry conditions; 25°C / 80% RH to cover extremely high humidity condition. Intertek offers cGMP-compliant pharmaceutical stability testing and ICH storage programs for a wide range of pharmaceuticals including biologics / biosimilars, inhaled and nasal drug products, solid, liquid dosage forms and other related healthcare products. Our stability studies are performed in fully cGMP validated and mapped stability chambers, which operate at ICH conditions (25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH) and at low temperatures (5°C, -20°C and -80°C). Merely applying the same requirements applicable to other markets could potentially lead to substandard products, e.g. 22 12-11-2011

stability studies conducted for countries 5°C. ICH stability studies Long-term stability under controlled storage conditions Stability testing, which is performed in suitable climate chambers at controlled temperature and relative humidity (r.h.) can be offered as part of formulation development projects, supply of pre-clinical material or as independent service package. Stability Testing of New drug Substances and Products Revision of ICH Q1A: Section of stress testing of active substance from glossary to the main text Text on test procedures brought in line with Q6A Text on testing frequency amended for accelerated conditions Storage conditions described in more detail. 30°C/65% RH. The stability of the finished products must be monitored according to a suitable and continuous program which will allow to detect any instability issue (e.g. STABILITY: The ability of a pharmaceutical product to retain its properties within specified limits throughout its shelf life. ICH Quality Guidelines for Pharmaceutical Stability Storage ... ICH’s recommended storage conditions: -80°C. Stability storage conditions BCM can offer: 25°C/60% RH. Stability data must demonstrate stability of the medicinal product throughout its intended shelf‐life under the climatic conditions prevalent in the target countries. The Guideline on stability testing for Climatic Zone III and IV takes up a proposal made by WHO and now defines not only storage conditions for stability testing relevant for the ICH tripartite regions (Europe, USA, Japan), but also completes the recommendations for the standardization of the storage conditions for the Climatic Zones III (dry-hot) and IV (very hot/humid). 2. Merely applying the same requirements applicable to other markets could potentially lead to substandard products, e.g. The existing WHO guideline on stability testing should be reviewed in the light of new information on climatic conditions in Zone IV as raised by the ASEAN countries. 2. The standard conditions for photostability testing are described in ICH Q1B. ICH STABILITY REQUIREMENTS Overcoming the Challenges Wayland Rushing, Ph.D. Director, Scientific Affairs.