Supplier Qualification & Vendor Management Flashcards

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

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

21 CFR 211.84 requires written procedures covering sampling, testing, and approval criteria for components, with documented evidence that each step was performed — spanning the full qualification lifecycle.

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

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

A Site Master File (SMF) provides a structured summary of the supplier's manufacturing operations, quality systems, and regulatory status, enabling the manufacturer to assess GMP compliance as part of qualification.

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)?

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

Risk-based supplier management tiers suppliers by their impact on product quality and patient safety; API suppliers are classified as high-risk requiring full GMP qualification, while non-GMP commodity suppliers need minimal oversight.

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

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

A merger or acquisition constitutes a significant organizational change that may alter quality systems, key personnel, and processes, triggering a re-qualification to confirm continued GMP compliance.

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

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

21 CFR 211.84 requires testing and approval of incoming materials, and 211.142 requires that contract facilities comply with GMP, obligating manufacturers to evaluate and audit contract laboratories.

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

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

Multi-sourcing critical materials reduces dependency on a single supplier, protecting against supply chain disruptions caused by supplier failures, regulatory actions, or force majeure events.

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?

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

Use of an unqualified supplier requires immediate batch quarantine, a formal deviation investigation to assess product quality impact, and initiation of the proper supplier qualification process going forward.