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

Document control ensures that only the most current, approved versions of documents are available for use and that obsolete versions are removed and archived.

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

21 CFR Part 211.188 requires batch production and control records to be retained for at least one year after the product's expiration date.

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

GxP regulations require corrections to be made with a single line-through so the original entry remains legible, followed by initialing, dating, and optionally noting a reason.

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 Master Batch Record is the master template that defines all steps, materials, specifications, and controls required to manufacture one batch of a product.

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

Controlled documents are tracked for revision status and distribution, ensuring users always have the current version; uncontrolled copies are informational only and not updated.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Documentation and Record Management