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

ICH Q10 explicitly states that the pharmaceutical quality system must include oversight of outsourced activities and quality of purchased materials, placing ultimate accountability on the manufacturer.

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

A formal impact assessment determines whether the supplier change affects product quality, regulatory filings, or validated processes before any disposition decision is made.

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

A SCAR is a formal communication requiring the supplier to investigate a quality failure, identify root cause, and implement verified corrective actions within a defined timeframe.

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

EU GMP Chapter 7 (not an Annex) governs outsourced activities; however, Annex 1 contains specific contractor provisions for sterile manufacturing. For contract work broadly, EU GMP Chapter 7 is the primary reference — a validation manager must know both.

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

Lack of cleaning validation for shared equipment presents a direct cross-contamination risk to product quality and patient safety, making it the most critical finding among the options.

CVM - Certified Validation Manager Practice Test

CVM - Certified Validation Manager Practice Test

CVM Supplier Qualification & Vendor Management 2