SQA SQA Documentation and Record Management

Question 1

What is the primary purpose of document control in a GxP quality system?

Accepted Answer

To ensure only current, approved documents are in use and obsolete documents are removed from circulation

Answer

To reduce the total number of documents in the quality system

Answer

To provide easy access to all historical document versions for staff

Answer

To automate document creation using standardized templates

Question 2

How long must US pharmaceutical manufacturers typically retain batch manufacturing records after product distribution?

Accepted Answer

At least one year after the product expiration date or three years after distribution, whichever is longer

Answer

Exactly two years from the date of manufacture regardless of expiry

Answer

Five years from the date of manufacture for all product types

Answer

Until the next scheduled regulatory inspection of the facility

Question 3

In GxP documentation, what is the correct way to correct an error in a paper record?

Accepted Answer

Draw a single line through the error, write the correction, initial, date, and optionally state a reason

Answer

Use white-out to cover the error completely before writing the correction

Answer

Tear out the page and rewrite the entire record from scratch

Answer

Erase the error completely and write the correct information over it

Question 4

What is a Master Batch Record (MBR) in pharmaceutical manufacturing?

Accepted Answer

A standardized template detailing all instructions, materials, equipment, and controls for manufacturing one product

Answer

A consolidated record of all batches manufactured in a calendar year

Answer

A document listing all approved raw material suppliers for a product

Answer

A record of environmental monitoring results for a manufacturing area

Question 5

What distinguishes a 'controlled document' from an uncontrolled copy in a GxP system?

Accepted Answer

A controlled document is a current, approved version tracked within the document control system; an uncontrolled copy is not tracked for revisions

Answer

A controlled document is stored in a locked cabinet; an uncontrolled copy is for open public access

Answer

A controlled document must be printed on specially colored paper for identification

Answer

A controlled document requires only one approver signature to become effective

Question 6

What is the purpose of an electronic document management system (EDMS) in a regulated environment?

Accepted Answer

To store, version control, route for approval, and distribute controlled documents electronically in a validated system

Answer

To scan and archive paper records for physical space savings only

Answer

To generate automatic audit reports for submission during FDA inspections

Answer

To replace all paper batch records with electronic equivalents