In
order to mimic current "Team Biologics" biannual inspection procedures
as closely as possible, Biologics Consulting Group, Inc. uses
two-person teams. One team-member with product expertise and the other with
cGMP expertise will 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
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