How PQS in Pharmaceutical Ensures Audit Readiness and Inspection Success

Why Audit Readiness Starts with PQS? 

In pharmaceutical manufacturing, audit readiness isn’t something to scramble for—it’s something to build into your everyday operations. A strong Pharmaceutical Quality System (PQS), as defined in ICH Q10, plays a central role in ensuring that every part of your process is aligned with regulatory expectations. 

Whether it’s an FDA inspection, WHO audit, or EU GMP review, a robust PQS ensures that you have the traceability, documentation, and control mechanisms to demonstrate quality at every step. 

What Is PQS in Pharmaceutical? 

PQS (Pharmaceutical Quality System) is a structured framework that governs how quality is maintained throughout the product lifecycle—from development to commercial production and distribution. ICH Q10 outlines four key elements of PQS: 

 Process Performance and Product Quality Monitoring 

 Corrective and Preventive Action (CAPA) 

 Change Management 

 Management Review 

Each of these elements plays a direct role in ensuring inspection readiness. Process Monitoring Builds Real-Time Audit Readiness 

✅ What It Does: 

This PQS element tracks critical process parameters and product quality attributes throughout manufacturing. 

✅ How It Supports Audits: 

 Enables real-time data access for auditors. 

 Demonstrates control over variability, preventing OOS/OOT. 

 Shows that the company proactively monitors trends (a key FDA expectation). 

Tip: Use trend analysis reports to show process consistency during inspections. 

 [Read how process control reduces OOS and OOT for a big pharma giant.] 

CAPA Ensures Traceable Resolution of Quality Issues 

✅ What It Does: 

The CAPA system within PQS tracks quality issues, investigations, root causes, and actions taken. 

✅ How It Supports Audits: 

 Auditors look for evidence that complaints, deviations, or audit findings are resolved systematically. 

 CAPA records show traceability from problem detection to preventive action. 

 Demonstrates regulatory compliance with 21 CFR Part 211.192 and 211.198. 

Best Practice: Use a digital CAPA dashboard to pull up live status of open and closed actions during audits. 

Change Management Prevents Surprise Failures 

✅ What It Does: 

This element manages the impact of any changes to processes, materials, equipment, or documents. 

✅ How It Supports Audits: 

 Proves that changes are reviewed for risk before implementation. 

 Shows that changes have been assessed for regulatory impact and properly documented. 

 FDA and EU GMP expect formalized change control procedures tied to quality risk assessments. 

Example: During an audit, showing a change control log with risk assessments and QA approvals can reduce questions from inspectors. 

Regulatory Expectations: What Inspectors Look For 

Regulators from the FDA, EMA, and WHO expect your PQS to be: 

 Documented and Consistently Followed 
→ All procedures (SOPs, CAPA, complaints, change controls) must be current and in use. 

 Backed by Risk Management Principles 
→ Aligns with ICH Q9’s focus on evaluating risks before implementing changes or closing investigations. 

 Digitally Traceable (if possible) 
→ Inspectors often prefer systems that offer automated logs, audit trails, and real-time record retrieval. 

 Regularly Reviewed and Updated 
→ SOPs, trend reports, and process controls should be reviewed periodically to remain inspection-ready. 

How Digital Tools Strengthen PQS and Audit Readiness 

Systems like QEdge help pharma companies integrate and automate PQS functions: 

  Automated dashboards for CAPA, deviation, and complaint metrics 

  Centralized document control for SOPs, logs, and audit trails 

 Time-stamped audit trails to show who did what, when 

  Built-in compliance checks for FDA, EU GMP, WHO, and ICH standards 

  Change control workflows with real-time QA approval steps 

With QEdge, companies gain 24/7 audit readiness—not just reactive preparation.
🔗 Learn more: Explore QEdge Quality Management Platform