Conversations That Matter
No deviation’s Takeaways from ISPE France Conference – Outsourcing and Supplier Management in the Pharmaceutical Industry
Speaker: Jean-Denis Mallet – Former Inspector, Auditor, and Trainer
With over 350 inspections and 300 audits under his belt, the speaker offers a unique dual lens—one forged in the rigour of regulatory enforcement, the other in the practical realities of GMP auditing.
His talk centered on a deceptively simple question:
How should audits and GMP-related activities be externalized—practically and in line with regulations?
Redefining the Basics: Audit, Inspection, Self-Inspection
Before diving into outsourcing, the speaker lays out clear distinctions:
- Audit: A formal, voluntary evaluation process between two parties, based on shared rules and mutual improvement.
- Inspection: A non-voluntary, often unannounced intervention led by authorities.
- Self-inspection: An internal compliance check, often hindered by bias.
“It’s like judging whether your own children are the most charming—you’ll never be entirely objective.”
Why Do Companies Outsource Audits?
Several practical reasons emerge:
- Lack of internal resources: Teams are often at full capacity.
- Time constraints: Internal schedules don’t always allow for urgent or ad hoc audits.
- Fresh perspective: External auditors see things internal teams may overlook.
- Specialised expertise: Especially useful during mergers, acquisitions, or niche processes.
- Efficiency & insight: External formats can inspire new ways of thinking.
“Sometimes you just need someone outside to say, ‘Why don’t you do it this way?’”
Remote Audits: Useful, But Not Ideal
While remote audits became essential during COVID, the speaker warns not to overestimate their value:
“You won’t see a mouse running across the room via a webcam.”
They are better than nothing, but can’t replace physical presence when it comes to truly assessing GMP compliance.
Auditing Your Suppliers: Still Essential
Even if a subcontractor is regularly inspected by authorities, it doesn’t replace your audit.
Why? Because:
- Regulatory inspections are general.
- Your audit should focus on your product, your process, and your risk.
“Don’t duplicate the inspection—complement it.”
Service Providers: Know Who You’re Hiring
The speaker uses pest control as a case in point:
- Do they understand the facility layout?
- Do they know where rodents actually get in?
- Do they understand your GMP environment?
This may seem trivial—until it’s not. Small details matter.
Audit Costs and Group Approaches
- Average cost cited: €12,000
- Possible solution: Group audits—shared resources, shared influence
But be warned: - It requires highly skilled, diplomatic auditors.
- Diverging interests among companies may skew outcomes.
The Regulatory Framework: GMP Guidelines Matter
Key references discussed:
- Chapter 7 (EU GMP): Subcontractors must be qualified before the first order.
- Chapter 9: Self-inspections must be done by competent internal personnel.
- Clause 5.29 (Vol. 4): Manufacturers must be audited to confirm GMP (and GDP/GVP/GCP when applicable).
“Yes, you can get help. No, you cannot outsource accountability.”
What Makes a Good Auditor?
Top selection criteria include:
- Clear scope definition (what to audit, against which standards)
- Relevant experience and sector expertise
- Objectivity and independence
- Strong communication and writing skills
- Planning & flexibility (especially for travel and disruptions)
- Ability to manage CAPAs effectively
- Rotation: Avoid sending the same auditor too often
“A good auditor doesn’t just spot the gaps—they help you think differently.”
Consultants Are Not Accountable
A recent GMP update (Clause 2.3) mirrors the U.S. approach:
“Consultants are not payers.”
They advise, but ultimate responsibility remains with the manufacturer.
Final Thoughts: Responsibility Can’t Be Outsourced
While outsourcing is a powerful lever for efficiency and expertise, one principle remains clear:
Responsibility always stays in-house.
Whether dealing with external auditors, subcontractors, or consultants—manufacturers must remain vigilant, accountable, and informed.
Want to go deeper?
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