IQ, OQ, PQ: Why Proper Equipment Qualification Matters in Compounding Pharmacies

Written By Jeff Gloyer

Introduction

In the world of sterile and non-sterile compounding, the reliability of equipment is directly tied to patient safety. Whether it’s a dry-heat oven, a laminar airflow hood, a depyrogenation chamber, an autoclave, or a mixing system, every piece of equipment used to produce compounded preparations must perform consistently and within defined specifications.

That’s where IQ/OQ/PQ—Installation Qualification, Operational Qualification, and Performance Qualification—comes in.

Despite being foundational elements of a compliant quality program, IQ/OQ/PQ is one of the most misunderstood and inconsistently executed requirements across 503A and 503B facilities. Many pharmacies think of qualification as a one-time event, a vendor responsibility, or a simple checklist. In reality, it’s a structured, science-driven process designed to ensure equipment continues to perform as intended over its life cycle.

This article breaks down what IQ, OQ, and PQ really mean, why they matter, and how proper qualification protects your patients, your business, and your regulatory standing.

What Is IQ/OQ/PQ? A Simple Breakdown

Installation Qualification (IQ): “Did we install it correctly?”

IQ confirms that equipment is:

  • Installed according to manufacturer specifications

  • Connected to appropriate utilities

  • Supported by required documentation

  • Controlled and traceable through asset management

IQ typically includes:

  • Verification of model, serial number, and configuration

  • Utility checks (electrical, HVAC, compressed air, etc.)

  • Calibration certificates

  • Manuals, schematics, and SOP references

  • Environmental requirements (clearances, ventilation, temp/humidity ranges)

Why it matters:
If the installation isn’t correct, nothing that follows can be trusted. IQ establishes a compliant baseline.

Operational Qualification (OQ): “Does it operate within defined limits?”

OQ tests the equipment’s functions without product load to ensure it behaves consistently under various operating conditions.

Common OQ elements include:

  • Control panel checks

  • Alarm and interlock verification

  • Timer and sensor accuracy

  • Temperature or pressure cycling

  • Airflow and filter integrity (for hoods)

OQ ensures the equipment responds properly to:

  • Upper and lower operating ranges

  • User inputs

  • Safety limits

  • Environmental influences

Why it matters:
OQ validates the equipment’s ability to operate correctly and safely—before it’s ever used for compounding.

Performance Qualification (PQ): “Can it perform as intended during real-world use?”

PQ proves that the equipment works in the way your facility will use it, with actual loads and operational conditions.

PQ includes:

  • Thermal mapping studies

  • Depyrogenation or sterilization load patterns

  • Media-fill considerations (when applicable)

  • Representative batch testing

  • Reproducibility checks

PQ must demonstrate consistent, repeatable performance.

Why it matters:
PQ is where regulators look most closely, because it bridges equipment capability with actual patient-impacting processes.

Performance Qualification

Thermal Mapping and Heat Penetration Study

Why IQ/OQ/PQ Matters for Compounding Pharmacies

Whether you are a 503A or 503B facility, proper equipment qualification is essential for:

1. USP <795>, <797>, <800> and FDA expectations

Regulators expect equipment to be qualified before use and throughout its lifecycle.
They also expect defensible documentation—not vendor brochures or incomplete checklists.

2. Patient safety

Incorrect temperatures, airflow inconsistencies, inaccurate mixing speeds, or faulty sterilization parameters can directly impact product quality.

3. Process validation

You cannot validate a process (like depyrogenation or sterilization) unless the equipment used in that process is qualified.

4. Preventing regulatory observations and 483s

Incomplete or poorly structured IQ/OQ/PQ documentation is a top observation in both 503A and 503B inspections.

5. Defensible engineering controls

Qualification creates a data trail that demonstrates your engineering systems work the way they should.

Common Problems Found During Pharmacy Inspections

Most pharmacies believe their equipment is “qualified,” but inspection findings often reveal gaps like:

  • Missing or incomplete IQ documentation

  • OQ testing not performed at min/max limits

  • PQ never completed or done incorrectly

  • Inadequate thermal mapping practices

  • No defined acceptance criteria

  • Vendor-performed IQ/OQ without facility-specific PQ

  • Outdated or unrepeatable test methods

  • No requalification schedule defined

These issues all create significant vulnerabilities during regulatory review.

How Often Should IQ/OQ/PQ Be Performed?

A common misconception is that qualification is a one-time event.
In reality, you must requalify equipment when:

  • Significant repairs occur

  • Equipment is moved

  • Software or control systems are updated

  • Preventive maintenance may affect performance

  • Environmental conditions change

  • A defined qualification interval is reached (often annually or biennially)

A strong qualification program includes:

  • A written lifecycle approach

  • Defined requalification triggers

  • Preventive maintenance integration

  • Change control alignment

How Pharmacy Solutions Consulting Helps

Our engineering-driven IQ/OQ/PQ services ensure your equipment:

✔ Is installed according to compliance standards
✔ Operates properly across intended ranges
✔ Performs consistently in real-use scenarios
✔ Has clear, defensible documentation
✔ Meets USP, FDA, and State Board expectations

Whether you are qualifying a single piece of equipment or developing a full qualification program, we provide practical, compliant, and science-based direction.

Conclusion

IQ/OQ/PQ isn’t busywork—it’s the foundation of safe, reliable compounding.
When performed correctly, qualification gives pharmacies confidence in their equipment, strengthens regulatory compliance, and supports patient safety in every batch produced.

If your facility needs support developing or executing qualification programs, we’re here to help.

Ready to strengthen your equipment qualification program?
Schedule a consultation and let’s ensure your systems are compliant, defensible, and engineered for long-term performance.

Jeff Gloyer