ICH quality guidelines

Release limits (acceptance criteria) are usually those negotiated between the FDA and the manufacturer of a drug substance. Additional information is available in the ICH quality guidelines. 

International Conference of Harmonization (ICH) Quality Guideline Q7A, Section 5.30 [3]... 

Review of compatibility data in this manner is important and useful in many cases. If Arrhenius treatment fits the decay observed in the compatibility samples, data obtained under relatively short-term accelerated stress conditions can efficiently be used to extrapolate the amount of decay expected at realistic long-term storage conditions. The adherence of decay to Arrhenius kinetics provides the formulator with a powerful tool for prediction and understanding of degradation. This decay model is the basis for the International Committee on Harmonization (ICH) quality guidelines... 

ICH Quality guidelines Q1 - Q12 can be found at http //www.ich.org/ products/guidelines/quality/article/quality-guidelines.html (accessed July 2015). 

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. 

As more than 95% of new medicines are worked out in the ICH regions the technical requirements for the safety, efficacy and quality of new medicines is determined at large by ICH technical guidelines. The application format for registration (marketing authorization) of new medicines in ICH and associated countries (such as Canada, Switzerland and Australia) has to follow The Common Technical Document (CTD) which provides harmonized structure and format for new product applications. This Common Technical Document is divided into four separate sections and 5 modules (see Fig. 1). The four sections address the application organization (M4 Organization), the Quality section (M4Q), the... 

Anonymous (2006), Quality guidelines, available http //www.ich.org/cache/compo/ 363-272-1. html. 

International Conference on Harmonization (ICH) (2000), Quality guideline, Q7A, ICH, Geneva. 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Quality Guidelines Impurities in New Drug Substances. http //www.ich.org/fileadmin/Public Web ... 

Site/ICH Products/Guidelines/Quality/Q3A R2/Step4/ Q3A R2 Guideline.pdf (accessed October 2012). 

Module II, Data Summaries (the GAIYO in Japanese), and Module III, Quality, Module IV, Safety, and Module V, Efficacy, are common to the ICH Regions. Please refer to the ICH M4 guidelines. 

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