ISO 15378:2017 - Primary Packaging for Medicines Lead Auditor Quiz 01 26Jul25 - Practice Quiz

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Question 1 of 30

During an audit of a primary packaging manufacturer for medicinal products, a significant non-conformity was identified concerning an unacceptable level of particulate contamination found in a batch of glass vials. The manufacturer implemented a corrective action plan, which included enhanced cleaning procedures for the vial washing equipment and stricter visual inspection protocols for incoming raw materials. As a lead auditor, which of the following approaches would provide the most robust evidence that the corrective action has effectively prevented the recurrence of this specific non-conformity?

Conducting a follow-up audit focused on the vial washing process and re-testing a statistically significant sample of vials from subsequent production batches under conditions that previously revealed the contamination.

Reviewing the documented training records for personnel involved in the vial washing and inspection processes to confirm they received updated instructions.

Obtaining a written confirmation from the supplier of the glass vials stating that their manufacturing process has been reviewed and no issues were found.

Verifying that the corrective action report has been completed, signed by the responsible manager, and filed in the quality management system documentation.

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