ICH stability guidelines

A more detailed description of stress testing is provided near the beginning of the ICH Stability guideline, under the Drug Substance heading ... 

MCC Circular 10/97 should be referred to. This circulcir is essentially the same as the ICH stability guideline for new chemical entities with a few concessions for generic medicines. The circular confirms the fact that it is a guideline and that there are scientificcilly justifiable reasons for using alternative approaches. 

Q5C Stability of Products. Step 5 The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. This forms an annex to the main ICH Stability Guideline (QIA above) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products, in which the active components are typically proteins and/or polypeptides. 

Part 211.166 (b) stipulates that an adequate number of batches must be tested to determine an appropriate expiration date. However, the regulations do not specify what the number of batches is and the size of these batches. This information is further clarified with the issuance of ICH stability guidelines. Similar sets of samples are also placed at higher temperature and higher humidity conditions to speed up degradation. These accelerated conditions generate data that are used to establish tentative expiration dates. Most studies use 40°C/75% Relative Humidity (RH) as the accelerated condition. This condition is also the ICH-accelerated condition. 

The frequency of testing is similar to the ICH stability guideline, in other words, at 0,3,6,9,12,18 and 24 months for studies at long-term conditions, and at 0,3 and 6 months for accelerated conditions. For GMP maintenance studies the frequency is every 12 months (Item 4 of the resolution). 

The new Chinese Pharmacopoeia 2005 (CP 2005) [24], which came into effect on 1 July 2005, provides guidance for stability testing. In principle, these testing conditions are in accordance with the ICH stability guideline Q1A(R2) specified for countries in Climatic Zone II [25]. The key elements of these conditions are summarised as follows and the difference to the ICH guideline is highlighted ... 

Concerning aqueous-based products packaged in semi-permeable containers, the recommended long-term and accelerated storage conditions are described in the ICH stability guideline Q1A(2R). 

The WHO has established several separate parent guidelines on stability testing that covers the countries around the world. The WHO guidelines are aligned with the ICH stability guidelines for countries that fall within the climatic zones I and II. The WHO guidelines establish guidelines for the zones III, IVa, and... 

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