In order to mimic current "Team Biologics" biannual inspection procedures as closely as possible, the Biologics Consulting Group, Inc. uses two-person teams, one with product expertise and the other with cGMP expertise, to perform "mock" FDA inspections. The aim of these inspections is to identify potential compliance problems and to help structure corrective actions prior to an actual FDA inspection.

Pre-Approval Inspection Team: Biologics Consulting Group, Inc. offers a comprehensive team approach to help manufacturers prepare for a pre-approval inspection (PAI). The program includes:

• Inspection of manufacturing facility(ies)

• Audit of system/process validation studies

• Evaluation of company Quality System

• Evaluation of company plans and procedures for managing the PAI

• GLP Audits

• Quality Systems Audits