Inspection & Audit Management

Inspection Management

The management of any Health Authority Inspections is crucial to any company in the regulated space. Depending on the scope of the activities of a site as well as the geographic intended or current Supply Chain, various Health Authorities will be performing either on-site or paper-based Inspections.

PRO Pharma Consulting will be able to support you in the preparation, training, execution, and post-inspection process. The principle consultant has exerience as an inspection host of more than 30 inspections of Swissmedic/regional inspectorates, FDA, ANVISA, Turkish MoH, Korean MFDS, Russian MIT, and Gulf Coast Countries Cooperation.

Audit Management

Auditing of Suppliers and Service Providers is another important activity in Quality management. A risk-based approach is generally used to focus on the high-risk areas. The accountability of the Quality and the cGMP-compliance of services resides with the company. Solid audit processes therefore form an important element on securing the Quality and the QA Compliance of any supplied pharmaceutical product or medical device.

PRO Pharma Consulting is able to execute audits on an individual basis in the GDP and GMP area with a focus on small molecules, and solid/liquid non-sterile as well as sterile forms.