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

'Current' signifies that GMP standards evolve with technological advances — manufacturers must adopt the most up-to-date practices, not just meet historical minimum standards.

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 unplanned departure from approved procedures or specifications; it must be documented, investigated to find root cause, and evaluated to determine whether affected product meets quality standards.

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

Answer

EM programs sample cleanroom air, surfaces, equipment, and personnel to detect microbial and particle contamination trends and ensure the controlled environment remains within specified limits.

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

Change control is a quality system that ensures all modifications to validated processes, equipment, materials, or procedures are evaluated for quality impact and formally approved before implementation.

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

An OOS result is any analytical result that falls outside established acceptance criteria — requiring investigation before product disposition decisions.

BACE - Biotechnician Assistant Credentialing Exam Practice Test

BACE - Biotechnician Assistant Credentialing Exam Practice Test

BACE Good Manufacturing Practices (cGMP) 2