What Packaging Component Supplier Audits Cover
Packaging components that come into direct contact with product can affect quality, stability, and safety. Primary packaging includes vials, syringes, blisters, and closures. These materials must be controlled.
A GMP audit for packaging component suppliers assesses whether the supplier meets GMP requirements, whether materials are controlled, whether extractables and leachables are addressed, and whether change control is in place. The scope includes materials, manufacturing, testing, and documentation.
The Regulatory Context
FDA 21 CFR 211 Subpart E and G
The FDA sets requirements for control of components and packaging materials.
EU GMP Chapter 3 and Chapter 5
Chapter 3 covers premises and equipment. Chapter 5 covers production, including packaging.
ICH Q3 and Extractables
ICH Q3 covers impurities, and related guidance covers extractables and leachables from packaging.
PIC/S and WHO
PIC/S Guide PE 009 and WHO GMP guidelines cover packaging materials.
What Audits Focus On
Materials
Materials should be controlled. The audit should check that specifications are defined.
Manufacturing
Manufacturing should be controlled. The audit should check that processes are validated.
Testing
Testing should be performed. The audit should check that testing is complete.
Extractables and Leachables
Extractables and leachables should be addressed. The audit should check that studies are performed.
Change Control
Changes should be controlled. The audit should check that changes are communicated.
Common Findings in Packaging Component Supplier Audits
Materials That Are Not Controlled
Manufacturing That Is Not Validated
Testing Gaps
Extractables and Leachables Gaps
Change Control Gaps
Introducing GxP Cellators for Packaging Component Supplier Audits
GxP Cellators provides GMP audits for packaging component suppliers covering materials, manufacturing, testing, extractables and leachables, and change control.
We work across FDA, EMA, Health Canada, MHRA, WHO, and PIC/S frameworks. Our auditors bring regulatory inspection and industry quality experience, and we deliver clear, prioritized reports with practical remediation guidance.
Control Packaging Materials
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your packaging supplier audit.
Frequently Asked Questions About Packaging Component Supplier Audits
Why are primary packaging materials important?
They come into direct contact with product and can affect quality and safety.
What are extractables and leachables?
Extractables are substances that can be extracted from packaging under certain conditions. Leachables are substances that migrate into the product.
How do you assess change control?
We review whether changes are communicated and whether impact is assessed.
Can you help us prepare for an inspection of packaging suppliers?
Yes. We conduct readiness reviews and mock inspections.
How do I request a packaging supplier audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
