USFDA Audit Preparation Checklist – Quality Control

1. Laboratory Infrastructure & Environment

• Lab layout complies with GMP (segregation of microbiology, chemistry, stability).

• Controlled access to QC labs (only authorized staff).

• Housekeeping and cleanliness records maintained.

• Environmental monitoring (temperature, humidity, differential pressure) documented.

• Safety equipment (fume hoods, biosafety cabinets, fire extinguishers) validated and maintained.

2. Instruments & Equipment

• Qualification status (IQ/OQ/PQ) of all instruments available.

• Preventive maintenance and calibration records up to date.

• Audit trail enabled and reviewed for computerized systems (21 CFR Part 11 compliance).

• Equipment logbooks complete, contemporaneous, and signed.

• Out-of-service instruments labeled and segregated.

3. Analytical Method Validation & Transfer

• Analytical methods validated as per ICH/USP requirements.

• Validation reports available and approved.

• Method transfer protocols and reports documented.

• System suitability tests performed and documented.

• Updates in pharmacopeia reflected in lab methods (traceability maintained).

4. Raw Data & Documentation (Data Integrity)

• All raw data retained (chromatograms, spectra, balances printouts).

• Records comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

• Audit trails reviewed and documented periodically.

• Manual entries signed, dated, and verified.

• No evidence of data manipulation (backdating, overwriting).

5. Sample Management

• Proper receipt, labeling, and storage of samples.

• Chain of custody maintained for samples.

• Reference standards and working standards properly qualified, labeled, and stored.

• Stability samples placed and pulled as per approved protocol.

• Sample disposal records maintained.

6. Testing & Results

• Testing performed as per approved specifications and methods.

• Out-of-Specification (OOS), Out-of-Trend (OOT), and deviations handled per SOP.

• Retesting/reanalysis procedure followed as per guidance.

• Calculations checked and verified.

• QC checks before data release documented.

7. Microbiology Laboratory (if applicable)

• Area qualification and environmental monitoring records maintained.

• Media preparation, sterilization, and growth promotion test (GPT) records available.

• Water and cleanroom microbial monitoring data maintained.

• Proper segregation of sterile and non-sterile testing areas.

• Positive and negative controls documented.

8. Stability Studies

• Approved stability protocols in place.

• Chambers qualified and monitored (temperature/humidity mapping).

• Stability study pull points documented and followed.

• Stability testing results recorded and reviewed.

• Stability commitments to regulatory agencies tracked.

9. Training & Personnel

• Training records available for all QC staff.

• Training on GMP, GDP, data integrity, and laboratory safety documented.

• Analysts qualified for specific instruments and tests.

• Personnel hygiene and gowning practices followed.

10. Regulatory Compliance & Readiness

• Laboratory SOPs reviewed, updated, and aligned with current USFDA/ICH guidelines.

• Internal audits and self-inspections performed with CAPA implementation.

• Previous regulatory inspection observations closed and documented.

• Mock audits conducted for readiness.

• Readiness of staff for interviews during FDA inspection (knowledge of their tasks, SOPs, data integrity).

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