ICH guidelines for API

ICH guidelines for API are guidelines from the ICH specific to the active pharmaceutical ingredient (API) of the drug. A small note about ICH Q7:

The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). The scope of this guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.

When did it come into effect?

The International Conference of Harmonization (ICH), which was adapted in November 2000, formulated the ICH Q7.  After concurrence from three of the world’s leading medical device markets, namely the EU, Japan and the US; this instrument was executed.

ICH guidelines for API

ICH guidelines for API come under a section of the ICH Q7 that is devoted to this aspect of a drug. ICH guidelines for API relate to these important aspects of a drug’s API:

Stress testing: whenever available, data published in scientific publications aimed at supporting the identified degradation products and pathways should be provided. If these data are not available; stress testing has to be carried out.

Selection of batches:normally, data from stability studies on at least three primary batches of the API should be provided. For those existing active substances that are known to be stable; data from two primary batches are sufficient.

Container closure system: ICH guidelines for API state that the stability studies should be conducted on the API packaged in a container closure system that is similar to, or ape, the packaging proposed for storage and distribution.

Specification: in these studies, testing of those attributes of the API that are susceptible to change during storage and could influence quality, safety and/or efficacy should be included.

Testing frequency: ICH guidelines for API state thatthe frequency of testing should be sufficient to establish the stability profile of the API for long-term studies.

Storage conditions: an API should be evaluated under storage conditions (with relevant and necessary tolerances) that test its thermal stability and, if applicable, its 91 sensitivity to moisture. Here, it is stated that both the storage conditions and the lengths of studies chosen should be enough to cover storage and shipment.

ICH guidelines for API for Active pharmaceutical ingredients intended for storage below -20°C

The ICH has guidelines for API that is intended for storage below -20°C.

These are:

Stability commitment


Statements and labelling

On-going stability studies




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