SQA SQA Documentation and Record Management 1 — Questions and Answers
Question 1: What is the primary purpose of document control in a GxP quality system?
- To ensure only current, approved documents are in use and obsolete documents are removed from circulation (Correct answer)
- To reduce the total number of documents in the quality system
- To provide easy access to all historical document versions for staff
- To automate document creation using standardized templates
Correct 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.
Question 2: How long must US pharmaceutical manufacturers typically retain batch manufacturing records after product distribution?
- At least one year after the product expiration date or three years after distribution, whichever is longer (Correct answer)
- Exactly two years from the date of manufacture regardless of expiry
- Five years from the date of manufacture for all product types
- Until the next scheduled regulatory inspection of the facility
Correct 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.
Question 3: In GxP documentation, what is the correct way to correct an error in a paper record?
- Draw a single line through the error, write the correction, initial, date, and optionally state a reason (Correct answer)
- Use white-out to cover the error completely before writing the correction
- Tear out the page and rewrite the entire record from scratch
- Erase the error completely and write the correct information over it
Correct 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.
Question 4: What is a Master Batch Record (MBR) in pharmaceutical manufacturing?
- A standardized template detailing all instructions, materials, equipment, and controls for manufacturing one product (Correct answer)
- A consolidated record of all batches manufactured in a calendar year
- A document listing all approved raw material suppliers for a product
- A record of environmental monitoring results for a manufacturing area
Correct 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.
Question 5: What distinguishes a 'controlled document' from an uncontrolled copy in a GxP system?
- A controlled document is a current, approved version tracked within the document control system; an uncontrolled copy is not tracked for revisions (Correct answer)
- A controlled document is stored in a locked cabinet; an uncontrolled copy is for open public access
- A controlled document must be printed on specially colored paper for identification
- A controlled document requires only one approver signature to become effective
Correct 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.
Question 6: What is the purpose of an electronic document management system (EDMS) in a regulated environment?
- To store, version control, route for approval, and distribute controlled documents electronically in a validated system (Correct answer)
- To scan and archive paper records for physical space savings only
- To generate automatic audit reports for submission during FDA inspections
- To replace all paper batch records with electronic equivalents
Correct 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.
SQA SQA Documentation and Record Management 1
What is the primary purpose of document control in a GxP quality system?