International Conference Harmonization guidelines

The method was validated in accordance to the guidelines of the international conference on harmonization (ICH). Data with respect to accuracy, within- and between run precision, recovery, detection and quantitation limits were reported and found to be within the accepted international criteria. Neither endogeneous substances nor the commonly used dmgs were found to interfere with the retention times of the analytes. Standard solutions of the dmg and quality control preparations at high and low level concentrations were demonstrated to be stable at room temperature and/or -20°C for long and short periods of time. 

Fig. 13-1. International Conference on Harmonization (ICH) process for developing harmonized guidelines.

International Conference on Harmonization, Guideline on validation of analytical procedures definition and terminology, Fed. Reg., 60(40), 11260 (1995). 

Harmonization (ICH), 18 688 in fine chemical production, 11 435 guidelines, 21 168, 169 International Conference on... 

ISO 10993-3 (1993) sets forth clear guidance on testing requirements as summarized in Table 6.1. ICH (International Conference on Harmonization) guidance, shown in Table 6.2, has different but also clear requirements. They want to see an in vivo test conducted. While FDA has no clear guidelines, it expects that an appropriate adaptation of one of these two be performed. 

FDA International Conference on Harmonization Guideline on detection of toxicity to reproduction for medicinal products. Federal Register, September 22, 1994, Vol. 59, No. 183. 

Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline. Journal of Clinical Pharmacology, 46, 498-507. 

International Conference on Harmonization Q6A Guideline Specifications for new drug substances and products Chemical Substances, October 1999. 

Source International Conference on Harmonization. Safety Guidelines, http //www.ich.org/ cache/compo/502-272-l.html [accessed September 17,2007]. 

International Conference on Harmonization. Organization of the common technical document for the registration of pharmaceuticals for human use, in Harmonized Tripartite Guideline, ICH, 2002. 

With the formation of the International Conference on Harmonization (ICH), the GMP guidelines are presented in Q7.This document has been adopted by the United States, the European Union, and Japan. 

---