Manufacturing
Pre-Approval Inspection(PAI)
In one line
FDA inspection of a manufacturing facility prior to PMA approval.
Definition
A Pre-Approval Inspection assesses whether the manufacturing site, processes, and quality systems are in a state of control sufficient to support PMA approval.
FDA inspects the manufacturing sites named in a PMA, usually during the review, and approval depends on a satisfactory result. Investigators check that the quality system meets Part 820 and that the device can be made consistently to the specifications in the application. Observations are recorded on Form FDA 483 and must be resolved before approval.
Why it matters
PAI findings can delay or block PMA approvals. They also give FDA an early view into manufacturing capability.
Common pitfalls
- •A common pitfall is underestimating the thoroughness of a PAI, assuming that only documentation will be reviewed, when in fact direct observation of manufacturing processes and employee interviews are standard.
- •Another mistake is neglecting to conduct a comprehensive internal audit or mock PAI prior to the actual inspection, which can reveal weaknesses in the quality system.
- •Failing to adequately address issues identified during previous inspections or internal audits can lead to significant PAI findings and delays.
- •Inadequate training records or demonstration of employee competency often lead to PAI deficiencies, as these are direct indicators of a controlled manufacturing environment.
- •Not having clear, well-documented, and consistently followed procedures for all aspects of manufacturing and quality control can result in immediate PAI issues.
Sources
- FDA Inspection Resources · FDA
- GHTF/IMDRF Process Validation Guidance · IMDRF/GHTF
- FDA - Device Manufacturing · FDA