SQA Documentation and Record Management Flashcards

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

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

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

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

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

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.

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

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

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.

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

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

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

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

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

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

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

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

An EDMS provides a validated electronic platform for the full lifecycle management of controlled documents, including authoring, review, approval, distribution, and archival.