CVM Supplier Qualification & Vendor Management 3

Question 1

What information must be included in a written supplier qualification procedure to satisfy FDA 21 CFR Part 211 requirements?

Accepted Answer

Criteria for approval, testing requirements, periodic re-evaluation, and documentation of the qualification process

Answer

Supplier's proprietary pricing structures and discount schedules

Answer

The supplier's confidential customer list to confirm industry reputation

Answer

Only the approved material specifications and delivery lead times

Question 2

A validation manager is reviewing a supplier's site master file (SMF). What is the primary purpose of this document in supplier qualification?

Accepted Answer

To provide a comprehensive overview of the supplier's GMP operations, quality system, and regulatory compliance status

Answer

To serve as the binding contractual agreement between the manufacturer and supplier

Answer

To replace the need for an on-site audit of the supplier's facility

Answer

To document the financial terms and penalties for non-conforming shipments

Question 3

Under a risk-based approach to supplier management, how would a supplier of non-critical office supplies be classified compared to a supplier of an active pharmaceutical ingredient (API)?

Accepted Answer

The API supplier is higher risk and requires full GMP qualification; the office supply vendor requires minimal or no GMP qualification

Answer

Both require identical qualification procedures to ensure regulatory compliance

Answer

The office supply vendor requires more oversight due to higher procurement volume

Answer

Both require annual on-site audits under FDA regulations

Question 4

Which action is required when a qualified supplier is acquired by or merges with another company?

Accepted Answer

Conduct a re-qualification assessment to confirm that quality systems, personnel, and processes remain compliant after the organizational change

Answer

Automatically transfer the original qualification approval to the new corporate entity with no further review

Answer

Immediately suspend the supplier and source materials exclusively from backup vendors

Answer

Issue a SCAR to document the corporate change as a quality event

Question 5

What is the key regulatory basis for requiring manufacturers to audit contract laboratories that test drug products or components?

Accepted Answer

FDA 21 CFR 211.84 and 211.142, which require that contract laboratories comply with GMP and be evaluated for conformance

Answer

ISO 17025, which requires manufacturers to audit all external laboratories they engage

Answer

FDA 21 CFR 211.68, which governs computerized laboratory systems only

Answer

USP General Chapter <1> which mandates third-party laboratory audits

Question 6

In the context of supply chain integrity, what is the primary goal of implementing a dual- or multi-source strategy for critical materials?

Accepted Answer

To reduce the risk of supply disruption and ensure product availability if a primary supplier fails to deliver

Answer

To leverage competitive pricing by forcing suppliers to bid against each other

Answer

To satisfy FDA requirements that mandate multiple approved suppliers for all drug components

Answer

To simplify incoming testing by averaging results across multiple supplier CoAs

Question 7

A validation manager discovers that production has been using materials from an unqualified supplier for six months without approval. What is the correct sequence of actions?

Accepted Answer

Immediately quarantine affected batches, initiate a deviation investigation, assess product impact, and begin formal supplier qualification

Answer

Retroactively approve the supplier and document the qualification as complete

Answer

Destroy all affected product without investigation to eliminate regulatory exposure

Answer

Notify the FDA before conducting any internal investigation