Audit services

Audit services

Supplier qualifications, inspections, and audits are getting more and more important. It is a demanding task to perform all the necessary activities. Whenever you may need help, e.g. an external expert, an independent mind, or just somebody to do the work – we can help.

1. Auditing and supplier qualification
   Lionpharm audits production sites, service providers, and quality systems on your behalf in order to support your supplier qualification process. This may include audit of new (prospective) sites as well the support during an inspection of a non-EU site by European inspectors. Our service portfolio includes the following areas:
   • GMP
   • 21 CFR 210/211
   • GDP
   • ISO 9001/14
2. Pre-Inspection Audit
   We help you to get “fit for inspection” prior to an announced or suspected regulatory inspectorate visit e.g. medicinal product approval or inclusion of supplier qualification. This includes as well the preparation of an inspection of a non-EU site by European inspectors. Our service portfolio includes the following areas:
   • GMP
   • 21 CFR 210/211
   • GDP
   • ISO 9001/14