SQA SQA Documentation and Record Management 2

Question 1

What is a 'deviation' in the context of GxP manufacturing documentation?

Accepted Answer

Any unplanned departure from an approved procedure or specification during manufacturing or testing

Answer

A deviation is an unplanned event or non-conformance where a procedure was not followed as written or a specification was not met during production or testing.

Question 2

What is a 'change control' process in a pharmaceutical QMS?

Accepted Answer

A formal system for evaluating, approving, implementing, and documenting changes to processes, equipment, materials, or documents

Answer

Change control ensures that all modifications to GxP systems, processes, or documents are assessed for potential quality and compliance impact before implementation.

Question 3

What is the role of a 'record retention schedule' in a GxP quality system?

Accepted Answer

To define how long each type of regulated record must be kept and the conditions for storage and eventual disposal

Answer

A record retention schedule specifies the minimum retention periods for all GxP record types based on regulatory requirements, and the conditions for compliant storage and disposal.

Question 4

What must be included in a completed Batch Production Record (BPR) to demonstrate GMP compliance?

Accepted Answer

Actual quantities of materials used, equipment IDs, in-process results, date/time/operator initials for each step, and yield reconciliation

Answer

A complete BPR must contemporaneously capture all critical information including materials, equipment, process steps with operator attestation, in-process testing, and yield calculations.

Question 5

What is a 'periodic review' of SOPs in a GMP quality system?

Accepted Answer

A scheduled review to ensure SOPs remain accurate, current, and reflective of actual practice

Answer

Periodic review ensures SOPs are reviewed at regular intervals (typically every 2-3 years) to verify they still reflect current practices, regulations, and equipment.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Documentation and Record Management 2