Written from the deficiency categories regulators publish, not from named reports. Each entry shows the observation in the inspector's style, why it was cited, and the practice that would have prevented it.
Change management: changes implemented prior to approval
Change control CC-25-0112 revised the granulation end point in the batch record for product X. The first batch manufactured with the revised end point was completed on 18 March. The revised batch record was approved on 21 March, operator training was recorded on 25 March and the change control was approved for implementation on 28 March. Three further changes reviewed showed the same pattern.
Change management: replacements not assessed for equivalence
Review of maintenance work orders for the purified water system identified 14 component replacements over 18 months recorded as like-for-like. In six cases the replacement was from a different manufacturer or of a different material of construction, including a UV lamp of a different output and a pump seal of a different elastomer. No equivalence assessment was documented for any of the 14. The procedure permitted the maintenance technician to determine like-for-like status.
Change control CC-24-0387 replaced the coating pan exhaust fan with a unit of higher capacity. The impact assessment recorded 'no impact' for validation, regulatory, cleaning, stability and training, with no rationale, and was signed by the requesting engineer and QA only. Validation, regulatory affairs and production were not consulted. Subsequent deviation DEV-25-0041 attributed a coating uniformity drift to altered drying conditions resulting from the increased exhaust rate.
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.
The IT service management system recorded 41 changes to the validated laboratory data system over 24 months, including vendor patches, database maintenance, configuration changes to result calculation parameters and creation of administrator accounts. None was recorded in the site change control system, none had a QA-approved impact assessment and none had documented regression testing. The site's computerised system validation procedure stated that changes were controlled 'through the IT change process'.
