System Based Inspections - Laboratory Controls

Description:

FACT: Many organizations do not understand the FDA move to Systems Based Inspections. One of the focus areas for many inspections is the laboratory and it is important that laboratory personnel understand the FDA system based inspection technique and the type of things the FDA will look at when they decide to investigate the Laboratory Control System, what are the responsibilities of the laboratory and how the laboratory can prepare for the System Based Inspection.

Since 2001 the FDA has used a system based technique for the inspection of drug and biological production facilities. Although the Quality unit and the Quality System are always a part of the inspection, the system based technique focuses on the responsibilities of other units within the organization. This discussion focuses on the responsibilities of the laboratory within the systems based inspection concept and discusses:

• What constitutes the Laboratory Control System.
• The responsibilities of the Quality Control Laboratory.
• Responsibilities of the Quality unit.
• FDA 483 citations that have resulted from deficiencies in the Quality Control Laboratory and an analysis of the cause.
• The impact of the systems concept on the organization.