What Facility Design and Qualification Audits Cover
Facility design and qualification determine whether a building, its utilities, and its equipment are suitable for the products made there. Mistakes at this stage are expensive to correct later. A facility that is designed without GMP requirements in mind will struggle to comply, no matter how well it is operated.
A GMP audit for facility design and qualification assesses whether the design meets the requirements, whether qualification was performed correctly, and whether the facility as built matches the design. The scope includes user requirements, design qualification, installation qualification, operational qualification, performance qualification, layout, and utilities.
The Regulatory Context
EU GMP Chapter 3 and Annex 15
Chapter 3 of EudraLex Volume 4 covers premises and equipment. Annex 15 covers qualification and validation, including the qualification stages.
FDA 21 CFR 211 Subpart C
The FDA sets requirements for buildings and facilities in 21 CFR 211 Subpart C. Buildings must be clean, sanitary, and free of infestation.
ICH Q9 and Risk-Based Qualification
ICH Q9 provides the framework for risk assessment. Qualification effort should be proportionate to risk.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover facility design and qualification.
Also read: GMP Audit for Complaint Handling: Listening to the Market
What Audits Focus On
User Requirements
Requirements should define what the facility must achieve. The audit should check that requirements are complete and documented.
Design Qualification
Design should be verified against requirements. The audit should check that design qualification is performed and documented.
Installation Qualification
Installation should be verified against design. The audit should check that installation qualification is complete.
Operational Qualification
Operation should be verified across the intended range. The audit should check that operational qualification is complete.
Performance Qualification
Performance should be verified under production conditions. The audit should check that performance qualification is complete.
Layout and Flows
Layout should support personnel and material flows. The audit should check that flows prevent contamination and cross contamination.
Utilities
Utilities should be qualified and monitored. The audit should check that utilities meet requirements.
Common Findings in Facility Design and Qualification Audits
User Requirements That Are Incomplete
Design Qualification Gaps
Qualification That Does Not Reflect Intended Use
Layout That Does Not Support Flows
Utilities That Are Not Qualified
Documentation Gaps
Introducing GxP Cellators for Facility Design and Qualification Audits
GxP Cellators provides GMP audits for facility design and qualification covering user requirements, design qualification, installation qualification, operational qualification, performance qualification, layout, and utilities.
We work across FDA, EMA, Health Canada, MHRA, WHO, and PIC/S frameworks, and we adapt the audit scope to the facility and products. Our auditors bring regulatory inspection and industry quality experience, and we deliver clear, prioritized reports with practical remediation guidance.
Also read: GMP Audit for Change Control: Managing Change Without Risk
Build It Right
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your facility audit.
Frequently Asked Questions About Facility Design and Qualification Audits
What is design qualification?
Design qualification verifies that the design meets the user requirements and GMP expectations.
What is the difference between IQ, OQ, and PQ?
IQ verifies installation, OQ verifies operation across the intended range, and PQ verifies performance under production conditions.
Why is layout important?
Layout supports personnel and material flows and prevents contamination and cross contamination.
Can you help us prepare for an inspection of a new facility?
Yes. We conduct readiness reviews and mock inspections.
How do I request a facility audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
