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 planned change to an established manufacturing process requiring approval

Answer

A request submitted to update an existing standard operating procedure

Answer

A regulatory filing required for introducing a new product or process

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

A procedure for approving new employees before they begin GMP work

Answer

A method for tracking changes in product inventory across warehouse locations

Answer

A system for recording and investigating market complaints about products

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

To schedule when records must be reviewed by quality management each year

Answer

To establish how frequently records are backed up on electronic servers

Answer

To plan the annual schedule for regulatory submission documents

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

Only the final product release test result confirming the batch meets specifications

Answer

The names of all employees who were physically present in the manufacturing area

Answer

A list of all standard operating procedures referenced during the production run

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

An unannounced audit to verify operators are following SOPs as written

Answer

A review triggered only when a deviation occurs involving the procedure

Answer

An annual report on SOP compliance submitted to the FDA

Question 6

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

Accepted Answer

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

Answer

Quality records are maintained by QA only; controlled documents are maintained by operations only

Answer

Quality records require digital signatures; controlled documents require wet-ink signatures only

Answer

Quality records are temporary working documents; controlled documents are permanent references