RAC Quality Systems and GMP Questions and Answers

Question 1

An internal audit at a medical device manufacturer reveals that three separate production batches failed final inspection for the same dimensional specification over the past two months.
The issue was documented, and the non-conforming products were scrapped each time.
According to 21 CFR 820.100, which of the following actions is now required?

Accepted Answer

Initiate a corrective action to investigate the root cause of the failures.

Answer

Retrain all production operators on the specific inspection procedure.

Answer

Continue to monitor the trend at the next management review.

Answer

Issue a field correction for all distributed batches.

Question 2

For a pharmaceutical product manufactured and distributed in the United States, which document provides the complete, official manufacturing history of a finished batch, including all production and control records?

Accepted Answer

The Batch Production and Control Record (BPCR)

Answer

The Master Batch Record (MBR)

Answer

The Drug Master File (DMF)

Answer

The Standard Operating Procedure (SOP)

Question 3

A medical device company is finalizing the development of a new infusion pump. Which of the following activities BEST satisfies the requirement for Design Validation under 21 CFR 820.30(g)?

Accepted Answer

Simulating clinical use with intended users in a controlled environment to confirm user needs are met.

Answer

Performing software unit testing to ensure all code modules function as specified.

Answer

Conducting performance testing on the pump's motor to confirm it meets torque specifications.

Answer

Compiling the Device Master Record (DMR) to ensure all specifications are documented.

Question 4

During a scheduled management review, the Head of Quality presents data showing a negative trend in supplier performance, specifically an increase in late deliveries of a critical component. According to the Quality System Regulation (21 CFR 820.20), what is the MOST appropriate output of this review?

Accepted Answer

An assignment of an action item to investigate the supplier issue and a commitment of resources to address it.

Answer

A decision to increase the safety stock of the critical component to buffer against late deliveries.

Answer

A note in the meeting minutes to re-evaluate the trend at the next quarterly review.

Answer

A directive to the purchasing department to immediately find a new supplier.

Question 5

Under US GMP for pharmaceuticals (21 CFR Part 211), which of the following responsibilities and authorities is uniquely assigned to the Quality Control Unit (QCU)?

Accepted Answer

The final disposition (approval or rejection) of all drug product batches.

Answer

Executing the process validation protocols for new equipment.

Answer

Drafting and authoring all manufacturing Standard Operating Procedures (SOPs).

Answer

Performing routine environmental monitoring of the manufacturing facility.

Question 6

A pharmaceutical company implements a significant change to the manufacturing process for a commercially distributed sterile injectable drug. The change involves using a new, more efficient filtration system prior to aseptic filling. Which GMP action is required before the company can release product manufactured with the new process?

Accepted Answer

Completing process re-validation, including at least three successful Process Performance Qualification (PPQ) batches.

Answer

Submitting a "Changes Being Effected in 30 Days" (CBE-30) supplement to the NDA.

Answer

Performing a retrospective validation on the first 10 commercial batches.

Answer

Updating the Master Batch Record and training the operators on the new filtration system.