SQA SQA Regulatory Compliance and GxP 2

Question 1

What is a CAPA in the context of SQA regulatory compliance?

Accepted Answer

Corrective and Preventive Action

Answer

Compliance Audit Procedure Assessment

Answer

Critical Area Process Analysis

Answer

Controlled Action Performance Audit

Question 2

Which FDA regulation covers Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals?

Accepted Answer

21 CFR Parts 210 and 211

Answer

21 CFR Part 58

Answer

21 CFR Part 820

Answer

21 CFR Part 312

Question 3

What is the purpose of an FDA Form 483 issued during an inspection?

Accepted Answer

To list inspectional observations and potential violations found

Answer

To approve a facility for commercial manufacturing

Answer

To certify an auditor as GMP qualified

Answer

To grant an import license for foreign products

Question 4

What is an FDA Warning Letter?

Accepted Answer

An official FDA communication indicating significant regulatory violations requiring prompt corrective action

Answer

A preliminary notice of an upcoming routine inspection

Answer

A request for additional product testing samples

Answer

A routine notification about labeling updates

Question 5

Which concept requires that pharmaceutical manufacturing processes consistently reproduce output meeting predetermined specifications?

Accepted Answer

Process Validation

Answer

Risk Assessment

Answer

Change Control

Answer

Out-of-Specification Investigation

Question 6

In GxP compliance, what does 'data integrity' primarily require?

Accepted Answer

Data must be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA)

Answer

Data must be stored in encrypted databases only

Answer

Data must be reviewed by a third-party auditor monthly

Answer

Data must be printed and signed within 24 hours of collection