BACE Good Manufacturing Practices (cGMP) 2

Question 1

What does the 'c' in 'cGMP' stand for, and why is it significant?

Accepted Answer

'Current' indicating regulations reflect state-of-the-art technology and are updated as science advances

Answer

'Certified' indicating the facility has passed FDA inspection

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'Comprehensive' indicating all aspects of manufacturing are covered

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'Compliant' indicating the manufacturer follows all applicable laws

Question 2

Under cGMP, what is a 'deviation' and how must it be handled?

Accepted Answer

A deviation is a departure from an approved procedure or specification that must be documented, investigated for root cause, and assessed for product impact

Answer

A deviation is any product that fails specification testing and must be discarded

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A deviation refers to equipment calibration drift that requires immediate equipment replacement

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A deviation is a voluntary change to a manufacturing process that must be approved in advance

Question 3

What is the purpose of an Environmental Monitoring (EM) program in a cGMP cleanroom?

Accepted Answer

To periodically sample air, surfaces, and personnel for microbial and particulate contamination to ensure cleanroom performance

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To measure temperature and humidity for employee comfort

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To track energy consumption for ISO 14001 environmental compliance

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To monitor chemical vapor levels for OSHA compliance

Question 4

In cGMP, what is a 'change control' system designed to do?

Accepted Answer

Formally evaluate, approve, document, and assess the impact of any change to a validated process, equipment, or material before implementation

Answer

Manage production scheduling changes due to supply chain disruptions

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Track changes to raw material prices for budget management

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Control employee shift changes to ensure qualified personnel are always present

Question 5

What is 'out of specification' (OOS) in the context of cGMP testing?

Accepted Answer

Any analytical test result that falls outside the acceptance criteria established in the product specification

Answer

A result that exceeds the upper specification limit only

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Equipment calibration results that fall outside maintenance intervals

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Any result obtained from an uncalibrated instrument

Question 6

Which of the following best describes the purpose of a 'batch record' in cGMP manufacturing?

Accepted Answer

A complete chronological documentation of all steps, materials, equipment, and measurements for a specific production lot

Answer

A record of employee training for the production team assigned to a batch

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A financial record tracking the cost of materials used in a manufacturing batch

Answer

A summary of QC test results for a batch submitted to the FDA