In the context of ICH Q7, contract manufacturing is the outsourced activity. The term ‘outsourced activities’, as defined and described in [ICH Q10, Section 2.7, Glossary], aligns with the description of ‘contract manufacturer’ in [ICH Q7, Section 16]. ICH Q7 defines ‘manufacture’ as ‘all operations of receipt of materials, production, packaging,
repackaging, labelling, relabeling, quality control, release, storage, and distribution of APIs and related controls.’
‘Related controls’ include any activities or services necessary to support production (e.g., maintenance, calibration, etc.). ICH Q7 applies to any activities performed by the original manufacturer or the company that is performing the activity on behalf of the original manufacturer.
