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

CAPA stands for Corrective and Preventive Action, a systematic FDA-required process to eliminate causes of non-conformances.

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 Parts 210 and 211 establish minimum cGMP requirements for the manufacture, processing, packing, and holding of drug products.

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

An FDA Form 483 is issued at the close of an inspection to list observations where investigators found conditions that may violate regulations.

Question 4

What is an FDA Warning Letter?

Accepted Answer

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

Answer

An FDA Warning Letter is a serious regulatory action notifying a company of significant violations that must be corrected or further enforcement will follow.

Question 5

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

Accepted Answer

Process Validation

Answer

Process Validation demonstrates that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Regulatory Compliance and GxP 2