RAC Quality Systems and GMP 2

Question 1

Under 21 CFR Part 211, which document must be prepared and followed for each batch of drug product?

Accepted Answer

Batch production record

Answer

Master batch record

Answer

Device history record

Answer

Design history file

Question 2

Which GMP regulation governs Current Good Manufacturing Practice for finished pharmaceuticals in the US?

Accepted Answer

21 CFR Part 211

Answer

21 CFR Part 820

Answer

21 CFR Part 600

Answer

21 CFR Part 110

Question 3

What is the primary purpose of an Annual Product Review (APR) in pharmaceutical manufacturing?

Accepted Answer

To assess consistency of existing processes and identify improvements

Answer

To satisfy FDA pre-approval inspection requirements

Answer

To validate new manufacturing equipment

Answer

To document supplier qualification activities

Question 4

In a GMP environment, which out-of-specification (OOS) investigation step must occur before retesting?

Accepted Answer

Phase I laboratory investigation

Answer

Regulatory notification

Answer

CAPA implementation

Answer

Batch disposition decision

Question 5

Which element is NOT a required component of a pharmaceutical quality system under ICH Q10?

Accepted Answer

Mandatory third-party audits

Answer

Management responsibility

Answer

Continual improvement of the process

Answer

Corrective and preventive action system

Question 6

What does the term 'qualification' refer to in the context of GMP equipment validation?

Accepted Answer

Demonstrating that equipment is properly installed, operates correctly, and performs as intended

Answer

Documenting that a process consistently produces a product meeting specifications

Answer

Verifying that analytical methods are suitable for their intended use

Answer

Confirming that suppliers meet quality standards

Question 7

Under 21 CFR 211.68, computerized systems used in drug manufacturing must have what safeguard?

Accepted Answer

Input/output verification to ensure accuracy

Answer

Dual-factor authentication for all users

Answer

Encryption of all stored data

Answer

Quarterly system revalidation