What the inspector wrote
Change control CC-24-0201 approved a change of supplier for the active substance of product Y. The regulatory impact assessment was recorded as 'not applicable'. The active substance manufacturer is a registered particular in the marketing authorisation and the change required a Type II variation. Nine batches manufactured with active substance from the new supplier had been certified and released to the EU market before the variation was submitted.
Why it was cited
A change to a registered particular implemented before the variation is approved means batches were manufactured outside the terms of the marketing authorisation. That is a critical deficiency regardless of the quality of the material, because certification by the QP under Annex 16 requires compliance with the authorisation.
The assessment was marked 'not applicable' by someone who did not consult the dossier. Regulatory impact is not a box on a form; it is a comparison between the change and Module 3, made by the function that holds Module 3.
What would have prevented it
- Make regulatory affairs a mandatory assessor for any change to a material, supplier, process, specification, method, site, equipment principle, batch size, shelf life or packaging, and require the assessment to cite the dossier section compared.
- Build the implementation constraint into the go-live approval: for Type IB, submission plus 30 days; for Type II, approval received. QA cannot approve go-live without the regulatory status on the record.
- Include a variation register reconciliation against the change control log in the PQR.