FDA PRE INSPECTION GAP ANALYSIS
21 CFR 820 / 211/111 COMPLIANCE SUPPORT
FDA 483 RESPONSE
USFDA TECHNICAL CONSULTATION

GAP Analysis

Procedures MUST be followed correctly if employees NOT practice or implemented in routine activities or practice that is wrong. GAP analysis from an expert find such compliance problem issues that an FDA inspector can find out —what is actually happening in the facility—and compare them against SOPs and regulations.

GAP ANALYIS will identify differences between actual activities and vs written SOPs. Once found, either the SOPs or the practices can be modified, resulting in a new updated procedure or system.

Whatever your compliance level, however, you are confident to face an FDA inspection, we would recommend even you should conduct a gap analysis from an experienced third party. This will always help you and avoid surprices during FDA inspection to certen level.

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