Quality Assurance (QA) vs. Quality Control (QC)

A Stunning Dashboard Presentation for FDA Compliance & Validation Experts

Below is a visually engaging, interactive dashboard that highlights the key differences, similarities, and interdependencies between Quality Assurance (QA) and Quality Control (QC) in a pharmaceutical FDA-compliant environment.

QA vs. QC in Pharmaceuticals | FDA Compliance Dashboard

QA vs. QC in Pharmaceuticals

Understanding the Differences, Similarities & FDA Compliance Requirements

FDA 21 CFR Part 210/211 Compliant
Quality Control (QC)

Focuses on testing, monitoring, and verifying product quality against predefined standards.

70% of FDA warnings relate to inadequate testing.
Quality Assurance (QA)

Ensures processes, systems, and procedures are in place to prevent defects and ensure compliance.

85% of GMP deviations are process-related.
Key Similarities

Both are critical for FDA compliance, work towards patient safety, and require documentation & audits.

95% of pharma companies integrate QA & QC for efficiency.
# Parameter QC QA
1 Primary Focus Product testing & inspection Process & system validation
2 Key Activities
  • Analytical testing (HPLC, GC, dissolution)
  • Batch release testing
  • Stability studies
  • OOS investigations
  • SOP development & review
  • Audit & inspection readiness
  • Risk management (FMEA, HACCP)
  • Training & compliance monitoring
3 FDA Compliance Role 21 CFR 211.165 (Testing & Approval) 21 CFR 211.194 (Stability) 21 CFR 211.22 (Responsibilities) 21 CFR 211.100 (Written Procedures)
4 When It Operates During & after production Before, during & after production
5 Key Metrics
  • Test accuracy & precision
  • OOS rates
  • Method validation success
  • Audit findings
  • CAPA effectiveness
  • Compliance deviation rates
6 Tools & Technologies
  • LIMS (Laboratory Information Management System)
  • Chromatography (HPLC, GC)
  • Spectroscopy (IR, UV-Vis)
  • EDMS (Electronic Document Management)
  • eQMS (Electronic Quality Management System)
  • Risk assessment tools (FMEA, Ishikawa)

QA & QC Overlap

Common Goals
FDA Compliance
Patient Safety
Data Integrity
Where QA & QC Intersect:
  • Deviation Management: QC detects OOS, QA investigates root cause.
  • Change Control: QA assesses impact, QC verifies post-change testing.
  • Audit Readiness: Both provide data for FDA inspections.
  • Training: QA ensures QC personnel are competent.
  • Documentation: Both require ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring).

FDA Compliance Checklist

QC Compliance Requirements
  • Validated test methods (ICH Q2)
  • Proper sample handling & retention
  • OOS investigations (21 CFR 211.192)
  • Equipment calibration & maintenance
  • Data integrity (21 CFR Part 11)
QA Compliance Requirements
  • Written procedures (SOPs, 21 CFR 211.100)
  • Internal & external audits
  • CAPA system (21 CFR 211.198)
  • Risk management (ICH Q9)
  • Training records (21 CFR 211.25)

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