How to do – Interpretation of ICH Q7 Guide


This document was written by experts from the European Industry (CEFIC APIC). It is essentially an interpretation of “how to” implement the ICH Q7 Guide based on practical experience. Other relevant publications (e.g. ISPE Baseline Guides, other ICH Guidelines) were taken into account and references included (if applicable with indication of the version at date of publication of the “how to do” document). This document does not intend to provide an exhaustive list of “how to” comply with the above-mentioned requirements and recommendations. It does however provide examples of commonly applied solutions and practical assistance on how requirements and recommendations can be met and /or interpreted. Industry should avoid needless paperwork and administrative burden.


As indicated in the Q7 document the focus should be - for the benefit of the patient - on identifying the critical controls and procedures that assure the quality of the API. Therefore, sound scientific judgement should prevail when setting up a quality system incorporating GMP.


You can access the ICH Q7 How to do Guide here.