SQA Documentation and Record Management Flashcards

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

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

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.

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

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

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

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

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

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.

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

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

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

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

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

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

In GxP record management, what is a 'quality record' versus a 'controlled document'?

Answer: Quality records are completed forms documenting activities performed; controlled documents are instructions or procedures to be followed

Controlled documents (SOPs, protocols) prescribe what to do, while quality records (logbooks, batch records) are the completed evidence that activities were performed as required.