How long before an audit should the readiness assessment start?
A typical pre-audit readiness assessment starts 2-3 months before the inspection.
GMP Audit Support
GMP audit support services for pharmaceutical manufacturers. The engagement covers the pre-audit readiness assessment, the mock audit, the documentation review, the inspector response, the CAPA, and the post-audit follow-up.
Pre-audit readiness
The pre-audit readiness covers the documentation review, the system walkthrough, the interview preparation, the tour preparation, the data review, the CAPA review, and the inspector scenario.
Mock audit
The mock audit covers the documentation request, the system walkthrough, the interview, the data review, the finding classification, and the CAPA recommendation.
Inspector response
The inspector response covers the data retrieval, the documentation provision, the interview support, the clarification, the commitment, and the follow-up.
Post-audit follow-up
The post-audit follow-up covers the CAPA development, the CAPA execution, the verification, the regulatory submission, and the continuous improvement.
How to use this page
Use this GMP Audit Support page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For GMP Audit Support, prepare the records, owners, risks and decision criteria linked to pre-audit readiness, mock audit, inspector response, post-audit follow-up. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
What is the difference between mock audit and real audit?
A mock audit is a simulated inspection conducted by the practice. A real audit is the actual inspection conducted by the regulatory authority.