Audit Preparation Programme for cGMP Industries
The Audit Preparation Programme:
This programme will assist companies in preparing for audits, specialising in FDA and IMB inspections. Prior to the inspection FLI will run a training course on audit preparation with the selected participants. FLI will provide coaching to the site inspection team before and during the audit. FLI will also undertake a mock audit of the relevant production area(s), laboratories, warehouse utilities etc.
As part of the mock audit FLI Group will review the relevant:
- Facility in which the product is manufactured including warehouse, process area, laboratories and utilities.
- Documentation including production data, laboratory records, validation data, training records, audit programs, vendor approval, deviation review, change control, document control, pest control, complaint handling, stability controls and gap position papers.
- On completion of the mock audit a comprehensive report will be issued. The report will be reviewed by senior site management and a corrective action plan will be put in place. On completion of the inspection we will provide support in the preparation of the inspection response.
Schedule:
Day 1 Audit Training Program.
Days 2 & 3 Mock Audit.
Day4 Prepare Audit Report.
Day 5 Review of Audit Report by Senior Site Management Team. Prepare corrective actions.
Additional Days (as required)
If you would like to discuss the FLI Group approach to GMP Audits, contact FLI Group at:
Enquiries: Contact us or phone 021 4350700