International Conference on Harmonization--critical discussion of the biotech 'Specifications' document

Since 1990, the International Conference on Harmonization (ICH) has served as the primary medium for the development of consistent, harmonized and scientifically based international standards that keep abreast of the complexity of rapidly evolving technologies, and health, safety and commerce issues. Of the 45 guidance documents generated to date, influencing the conduct of drug development at various points during its continuum, six are dedicated to biotechnology. 'Specifications', the last in the series, was completed in 1999. It is fully complimentary to the other five guidance documents in the ICH biotechnology compendium. The process of establishing product specifications (principles and applications) is functionally couched within the multifaceted strategy of ensuring quality and consistency, and is proving to be a fundamental resource in crafting future harmonized documents such as the Common Technical Document.