Why IQ/OQ/PQ and cGMP Validation Matter for Pharma Equipment

In pharmaceutical manufacturing, equipment is never “just hardware”. Whether you are installing a laser drilling system, an ODF coating line or a dissolution tester, regulators expect clear evidence that the machine has been installed correctly, operates as intended and performs reliably under real production conditions – all within a cGMP-compliant framework.

Terms like IQ, OQ, PQ and cGMP appear in almost every equipment project, yet their practical meaning is not always clear. This article briefly explains these concepts and shows how HUANGHAI supports customers with validation-ready equipment and documentation across different product lines. For an overview of HUANGHAI’s pharma-focused platforms, see our Pharma ODF Solutions and Pharmaceutical Testing Instruments .

IQ, OQ, PQ and cGMP in Simple Terms

Pharmaceutical regulations require that critical equipment is qualified and validated throughout its lifecycle. Four core concepts are:

• IQ – Installation Qualification
  Confirms that the equipment is installed according to the manufacturer’s specifications and approved design. IQ checks things like utilities, wiring, environmental conditions, software versions and documentation.
• OQ – Operational Qualification
  Verifies that the equipment functions correctly within its defined operating ranges. OQ tests alarms, safety systems, control loops, user interfaces and critical parameters against predefined acceptance criteria.
• PQ – Performance Qualification
  Demonstrates that the equipment can consistently deliver products meeting quality requirements under normal production conditions. PQ often uses actual or placebo product and covers multiple runs.
• cGMP – current Good Manufacturing Practice
  The overarching quality system that governs how medicines are made today. cGMP requirements apply to facility design, equipment construction, documentation, data integrity and ongoing change control.

Together, IQ/OQ/PQ and cGMP ensure that equipment is not only technically capable, but also implemented and used in a way that regulators can trust.

HUANGHAI’s Validation Approach Across Different Equipment Types

HUANGHAI designs equipment and documentation so that IQ/OQ/PQ can be executed efficiently at the customer site. The depth of features differs by equipment category, but the validation mindset is the same.

1. Large-Scale Production Equipment

For high-impact systems such as pharmaceutical laser drilling machines and integrated ODF coating / packaging lines, HUANGHAI combines cGMP design principles with advanced data and user management.

• Laser drilling systems (e.g. Olando K3-2) – Designed for tablet laser drilling with enclosure, dust collection and recipe control, these systems are prepared for 21 CFR Part 11 environments. Features typically include role-based user access, electronic signatures and audit trails, alongside structured IQ/OQ documentation templates.
• ODF coating and packaging lines (MJ series) – Continuous lines for ODF manufacturing are built with cGMP-compliant materials, cleanable layouts and safety interlocks. HUANGHAI provides detailed utility and instrument lists, functional descriptions and IQ/OQ protocols that customers can adopt or adapt for their validation master plans. A broader description of these platforms is available in our Pharmaceutical Film Manufacturing Solutions .

Because these systems are directly linked to product quality and data integrity, Part 11–ready functions and structured IQ/OQ support are built in from the start.

2. Pilot and Laboratory Equipment

Smaller machines such as pilot coaters, multi-purpose testers and degassing units are also part of the validated environment, especially when they support clinical or registration batches.

• Pilot coaters (e.g. BY-300A) – Designed following cGMP principles, with material traceability, clear operating ranges and documentation that supports IQ/OQ execution in R&D or pilot plants.
• Multi-purpose tablet testers (e.g. SY-6DN) – Combine hardness, dimensions and disintegration testing in a single device. These instruments are supplied with installation and operational qualification documents so that labs can quickly bring them into a qualified state.
• Supporting utilities (e.g. HTQ-1A vacuum degasser) – Even when not in direct contact with product, such units are documented with specifications and test plans that make it easier to prove they perform as intended.

By treating “small” equipment with the same cGMP mindset as large lines, HUANGHAI helps customers avoid weak spots in their validation landscape.

3. Pharmaceutical Testing Instruments

HUANGHAI’s portfolio of testing instruments covers dissolution, disintegration, hardness, friability and permeation tests, as summarized in the Pharmaceutical Testing Instruments overview.

These devices are built as GMP-ready, pharmacopeia-compliant instruments. While they generally do not include full Part 11 modules, they are supplied with:

• Operation manuals aligned with USP/EP/JP methods.
• Calibration and verification procedures.
• IQ/OQ documentation to support installation and functional checks.

This combination allows QC labs to validate instruments quickly and integrate them into their existing data management and documentation systems.

The Value of Robust IQ/OQ/PQ and cGMP Design

Investing in validation-ready equipment delivers value well beyond the purchase order. Complete IQ/OQ/PQ support helps customers to:

• Shorten project start-up – When the supplier has already prepared IQ/OQ protocols and design documentation, the user team can focus on site execution and PQ, rather than writing everything from scratch.
• Simplify audits and inspections – Validation documents provide a traceable link from user requirements and risk assessments to the tests performed. This transparency supports cGMP and data integrity expectations.
• Reduce operational risk – OQ and PQ testing identify potential issues (capacity limits, alarm behaviour, failure modes) before full-scale production, reducing the chance of unplanned downtime or non-conforming batches.

Planning Validation in a Lifecycle Framework

Modern regulations encourage a lifecycle approach to validation. Rather than treating IQ/OQ/PQ as isolated events, they are linked to earlier and later stages such as:

• URS – User Requirements Specification
• FS/DS – Functional and Design Specifications
• DQ – Design Qualification
• IQ/OQ/PQ – Installation, Operational and Performance Qualification

A good validation architecture traces each user requirement through risk assessments and design decisions to specific tests in IQ/OQ/PQ. HUANGHAI supports this approach by providing sample URS/FS content, design information and protocol templates that customers can integrate into their own quality systems.

When specifying new equipment, it is worth asking suppliers:

• Which documents are included to support URS, FS/DS and DQ?
• Are IQ and OQ protocols supplied, and can they be adapted to our internal format?
• What guidance is provided for PQ and ongoing periodic review?

Clear answers to these questions will make it easier to build a complete, regulator-ready validation package.

Conclusion: Validation as a Foundation, Not an Afterthought

Whether you are installing a large commercial line or a compact laboratory tester, IQ/OQ/PQ and cGMP design are fundamental to equipment performance and regulatory compliance. They turn machines into qualified assets that can withstand scrutiny from auditors and support robust, efficient production.

Across its product lines, HUANGHAI offers validation-ready designs and documentation, helping customers reduce project risk and accelerate time to routine operation.

If you are planning a new equipment project and would like to review validation support in detail, our team is available to help you map requirements to the right configuration and documentation package.

Contact HUANGHAI to discuss IQ/OQ/PQ and cGMP considerations for your next pharmaceutical equipment investment.