ICH guidelines - Glossary - peptidetesting.cc

ICH guidelines are globally harmonized scientific and technical standards for pharmaceutical registration. These rules are developed by the International Council for Harmonisation (ICH), a collaborative initiative between major regulatory authorities - including the US FDA, European EMA, and Japan's PMDA - and pharmaceutical industry experts to ensure international consistency.

ICH guidelines standardize method validation in laboratory testing

ICH guidelines standardize how laboratories validate analytical methods rather than testing substances directly. For example, ICH Q2 requires labs to prove method accuracy and precision, ICH Q6A provides the framework for acceptance criteria, and ICH Q3B sets thresholds for impurities. These standards ensure that laboratory testing follows globally recognized scientific procedures.

On a Certificate of Analysis (CoA), a claim that a method is "validated according to ICH guidelines" indicates that the laboratory followed these pharmaceutical-grade standards. Although ICH guidelines were designed for drugs seeking formal marketing authorization, vendors often apply them voluntarily to "research use only" (RUO) peptides to provide a standardized level of quality assurance.

Common confusions about ICH guidelines

ICH is not a specific test method, such as HPLC.
ICH is not a regulator; it writes the guidelines that authorities like the FDA adopt.
ICH is not GMP (Good Manufacturing Practice), which is a manufacturing quality system.
ICH is not a pharmacopeia, which publishes legally binding test methods for specific substances.

ICH guidelines standardize method validation in laboratory testing

Common confusions about ICH guidelines

Sources