BY PETER DEEGAN | LEAD AUDITOR COURSE LEAD TUTOR & PHARMACEUTICAL QA EXPERT
22nd JUNE
As you map out your supplier audit programme, you’re likely looking at a list that isn't all "classic" GMP. You have components, primary packaging, and excipient suppliers. They don't live in the world of EudraLex Volume 4, but rather the world of ISO 9001, ISO 15378, PS 9000 or Excipact.
So how do you audit them effectively? And more importantly, how do you assess whether an ISO-based Quality Management System (QMS) is equivalent to a GMP Pharmaceutical Quality System (PQS)?
It’s one of the most awkward dilemmas in pharmaceutical quality: You need a supplier to be compliant, but they don't actually have to follow your rules.
If you barge in and say, “We’re a GMP-regulated manufacturer - we’re kind of a big deal and you must comply with our standards,” don’t be surprised if you’re respectfully shown the door.
These suppliers often have their own Quality Management Systems (QMS) that work perfectly for them. In fact, many sell significantly higher volumes to the food or industrial sectors, that themselves often have higher controls, faster-moving packaging and labelling systems, and more time-sensitive manufacture than GMP could achieve. They could be as diverse as a farm producing snake-venom, animal extractable byproducts or plant extracts.
To them, the "pharma requirements" are often a headache they might not need; their paperwork may work for them, and they have good control, but they may not pass the strictures of GMP Part 1 Chapter 4 or MHRA data integrity. The question is, do they really need to?
Here is the catch: EU GMP Part 1 Chapter 7 requires us to assess the suitability of raw materials and component manufacturers. It doesn't say every supplier must work to GMP, but it does say you, the contract giver, must satisfy yourself that they are fit for purpose.
Auditing these "specialist" suppliers requires a much higher level of skill than a standard internal audit. You’re not just checking boxes; you’re performing full, risk-based equivalence assessments. You are responsible for translating their ISO language into your GMP needs.
This is exactly why we developed the IRCA-approved Lead Auditor for the Pharmaceutical Supply Chain course. We don’t just teach you the rules; we teach you how to negotiate two different worlds.
High-order auditing skills: We move beyond "internal audit" basics. We use real-world case studies - ranging from packaging systems to complex and diverse controlled manufacturing systems to test your ability to assess a non-GMP QMS against a Pharmaceutical QMS.
Mastering the ISO language: By using ISO 9001 as our core framework, we teach you to interpret a supplier’s system accurately. When you speak their language, your audit observations become more relevant, more useful and far more likely to be accepted and acted upon.
Deep dives into specialist standards: We train you explicitly on the standards that matter most in this space in terms of risk, focusing on packaging and labelling, including PQG PS 9000 and ISO 15378.
This was the best professional training I have ever received in my career to date. I encourage leaders to review training options and consider RSSL’s training classes for yourself and your teams.
Tracy Sienko | Lead Supplier Auditor - Pfizer
Learn more about our IRCA-approved Lead Auditor for the Pharmaceutical Supply Chain course here
Last year, sponsored by RSSL, I hosted the ‘My Auditing Journey’ podcast series. Former alumni Tracy Sienko and Sam Huff shared how this course transformed their approach to auditing complex, non-GMP suppliers.
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