Supplier audit: what a laboratory checks at a packaging manufacturer
A pharmaceutical laboratory does not pick a packaging manufacturer from a catalogue. Before the first order, it comes to see: it reads the procedures, traces a lot, looks at the workshop. That is the supplier audit.
By Tecmom editorial team · 2 min read
Why audit a packaging supplier
European good manufacturing practice requires primary and printed packaging materials to be handled with care comparable to that given to starting materials. The laboratory remains responsible for the quality of its medicine, including what its supplier does. It must therefore approve the supplier, then follow it over time.
The audit is the central tool of that approval. It is often prepared with a questionnaire, takes place on site, and ends with a report whose observations are graded by severity.
What the auditor looks at first
The quality system: certifications, procedures, management review, handling of complaints and deviations, corrective actions. For a manufacturer of primary packaging materials, the ISO 15378 standard often serves as the common reference.
Then traceability: can one trace a delivered lot of bottles back to the lot of material used, the machine, the mould and the shift? The auditor picks a lot and follows it, document after document.
The workshop and changes
On the shop floor, the auditor observes the production environment: cleanliness, staff gowning, lot segregation, line clearance between two runs, pest control. See our article on cleanroom moulding.
The auditor also examines change control: how a change of material, mould or machine is assessed, and how the customer is informed. It is often the most discussed point; see our article on change control.
After the audit
The findings lead to an action plan, which the auditor follows until it is closed. The approved supplier then enters a cycle of requalification: periodic audits, more frequent where the risk is higher, and monitoring of delivery performance.
ISO 19011 gives the guidelines for auditing management systems. Finally, the laboratory and its supplier set out their commitments in a quality agreement.
An audit is not an exam one passes once. It is the start of a relationship in which the supplier must be able to show, at any moment, what it did and why.
Glossary
- Supplier audit
- An on-site assessment of a supplier's quality system and practices.
- Approval
- The formal decision to accept a supplier after assessment.
- Line clearance
- A check that nothing from a previous run remains on the line.
- Requalification
- Periodic reassessment of an already approved supplier.