CVM Supplier Qualification & Vendor Management 2

Question 1

Under ICH Q10, which supplier management activity falls under the responsibility of the manufacturer's pharmaceutical quality system?

Accepted Answer

Oversight of outsourced activities and quality of purchased materials

Answer

Directing the supplier's internal production scheduling

Answer

Developing the supplier's internal SOPs and validation protocols

Answer

Managing the supplier's employee training programs

Question 2

A supplier notifies your organization of a planned change to their manufacturing process for a critical excipient. What is the correct first step under a supplier change management program?

Accepted Answer

Assess the potential impact of the change on your product quality and validation status

Answer

Immediately suspend shipments from the supplier until the change is approved

Answer

Issue a supplier corrective action request (SCAR) for unauthorized process modification

Answer

Update the Approved Supplier List to reflect the change as received

Question 3

What is the purpose of a Supplier Corrective Action Request (SCAR)?

Accepted Answer

To document and track required corrective actions after a supplier quality failure or audit finding

Answer

To formally request a price reduction following a quality failure

Answer

To notify the supplier that they have been removed from the Approved Supplier List

Answer

To establish new quality specifications for materials purchased from the supplier

Question 4

Which EU GMP Annex most specifically addresses the qualification and oversight of contract manufacturers and laboratories?

Accepted Answer

Annex 1 — Manufacture of Sterile Medicinal Products

Answer

Annex 11 — Computerised Systems

Answer

Annex 16 — Certification by a Qualified Person

Answer

Annex 7 — Manufacture of Herbal Medicinal Products

Question 5

During a supplier qualification audit, which finding would be considered most critical from a GMP compliance perspective?

Accepted Answer

Absence of documented cleaning validation for equipment shared between different product campaigns

Answer

Minor delays in updating internal SOPs following process improvements

Answer

Slightly longer-than-recommended training intervals for non-GMP staff

Answer

Use of a paper-based rather than electronic batch record system

Question 6

How should supplier performance metrics typically be structured in a vendor management program?

Accepted Answer

Using quality indicators such as CoA compliance rate, rejection rate, SCAR response time, and audit findings trends

Answer

Based solely on delivery timeliness and competitive pricing

Answer

Focused exclusively on financial stability and capacity indicators

Answer

Measured only during formal re-qualification audits conducted every five years

Question 7

When should a manufacturer initiate re-qualification of an already approved supplier?

Accepted Answer

When triggered by significant changes, quality failures, audit findings, or as defined by the risk-based requalification schedule

Answer

Only when the supplier requests re-evaluation after making improvements

Answer

Exclusively on a fixed 3-year cycle regardless of performance history

Answer

Only if the FDA issues a warning letter to the supplier