MHRA GDP INSPECTION PREPARATION
ANDY helps pharmaceutical wholesalers and quality teams test inspection readiness against published GDP expectations, controlled procedures and their own records—with every action remaining reviewable by the people accountable.
FROM READINESS QUESTION TO EVIDENCE
Start with the authorised activities, sites, product categories and quality-system areas likely to be examined. ANDY keeps the preparation task connected to the scope of the operation rather than producing a generic checklist.
Bring together controlled SOPs, self-inspection work, training evidence, deviations and CAPA status. Source-linked answers make it easier to distinguish a documented process from a process that can be demonstrated in practice.
Identify overdue actions, missing records, unclear ownership and places where procedure and practice do not align, while there is still time for an authorised team to investigate properly.
Structure readiness notes, evidence requests and draft response material without inventing records or presenting AI output as an approved inspection response.
Frame preparation around your licence scope, operating model, previous findings and current quality risks so effort follows the evidence an inspector is likely to test.
Link observations to regulatory material, controlled procedures and the records supplied to the assessment so reviewers can inspect the basis before relying on it.
Review overdue, repeated or weakly evidenced corrective actions alongside the deviations and self-inspections that generated them.
Use AI to organise and articulate working material while technical review, root-cause analysis, evidence verification and final approval remain human controls.
ANDY cannot certify that a site is compliant, guarantee an inspection result, create missing evidence or approve a response to MHRA. It helps teams organise, question and review the material that accountable people must verify and own.
QUESTIONS, ANSWERED
ANDY can help structure a readiness review around your stated licence scope, procedures and evidence. The resulting checklist is working material and must be checked against your actual operations and current regulatory sources.
It can support evidence review, structure and drafting. The organisation must verify every claim, perform the required technical and root-cause analysis, and have the response reviewed and approved by someone accountable.
No. A documented, risk-based self-inspection programme is part of the quality system. ANDY can help teams work with its outputs, but it does not perform or approve the underlying audit activity.
No software or adviser can guarantee an inspection outcome. ANDY supports evidence-led preparation while the condition of the quality system and the accuracy of the evidence remain the organisation’s responsibility.
READY WHEN YOU ARE
Start with a focused workspace for day-to-day compliance work, then bring your team and controlled knowledge with you.
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