manufacture and distribution of medicine
GMP and GDP Auditing Services
A comprehensive service – tailored to your organisation’s needs. We audit manufacturing facilities (solid dose, injectables, creams, ointments, liquids as well as APIs), affiliate offices, and contracted warehouses according to the provisions of Good Manufacturing Practices and Good Distribution Practices.
From creating, maintaining and tracking audit schedules, our auditors plan and lead audits. We issue audit reports (IPS or client report formats), track observations through CAPA and perform audit closure.
- Pre-inspection gap analysis audits (see section on Regulatory Inspections Preparation).
- Pharmaceutical audits of UK and Global Manufacturing and affiliate facilities to EU GMP
- Pharmaceutical GDP audits of UK based affiliates, contracted warehouses and transportation companies
- Pharmaceutical GDP audits of Global affiliates, contracted warehouses and transportation companies
- (countries and global sectors covered to date) Australia; United States; China; India; Europe (most countries – Eastern, Northern and Southern);
- New Vendor Selection Due diligence audits
- Of potential new contract warehouses
- And submitting recommendations as part of the selection process