SQA SQA Documentation and Record Management 2 — Questions and Answers
Question 1: What is a 'deviation' in the context of GxP manufacturing documentation?
- Any unplanned departure from an approved procedure or specification during manufacturing or testing (Correct answer)
- A planned change to an established manufacturing process requiring approval
- A request submitted to update an existing standard operating procedure
- A regulatory filing required for introducing a new product or process
Correct answer: Any unplanned departure from an approved procedure or specification during manufacturing or testing
A deviation is an unplanned event or non-conformance where a procedure was not followed as written or a specification was not met during production or testing.
Question 2: What is a 'change control' process in a pharmaceutical QMS?
- A formal system for evaluating, approving, implementing, and documenting changes to processes, equipment, materials, or documents (Correct answer)
- A procedure for approving new employees before they begin GMP work
- A method for tracking changes in product inventory across warehouse locations
- A system for recording and investigating market complaints about products
Correct answer: A formal system for evaluating, approving, implementing, and documenting changes to processes, equipment, materials, or documents
Change control ensures that all modifications to GxP systems, processes, or documents are assessed for potential quality and compliance impact before implementation.
Question 3: What is the role of a 'record retention schedule' in a GxP quality system?
- To define how long each type of regulated record must be kept and the conditions for storage and eventual disposal (Correct answer)
- To schedule when records must be reviewed by quality management each year
- To establish how frequently records are backed up on electronic servers
- To plan the annual schedule for regulatory submission documents
Correct answer: To define how long each type of regulated record must be kept and the conditions for storage and eventual disposal
A record retention schedule specifies the minimum retention periods for all GxP record types based on regulatory requirements, and the conditions for compliant storage and disposal.
Question 4: What must be included in a completed Batch Production Record (BPR) to demonstrate GMP compliance?
- Actual quantities of materials used, equipment IDs, in-process results, date/time/operator initials for each step, and yield reconciliation (Correct answer)
- Only the final product release test result confirming the batch meets specifications
- The names of all employees who were physically present in the manufacturing area
- A list of all standard operating procedures referenced during the production run
Correct answer: Actual quantities of materials used, equipment IDs, in-process results, date/time/operator initials for each step, and yield reconciliation
A complete BPR must contemporaneously capture all critical information including materials, equipment, process steps with operator attestation, in-process testing, and yield calculations.
Question 5: What is a 'periodic review' of SOPs in a GMP quality system?
- A scheduled review to ensure SOPs remain accurate, current, and reflective of actual practice (Correct answer)
- An unannounced audit to verify operators are following SOPs as written
- A review triggered only when a deviation occurs involving the procedure
- An annual report on SOP compliance submitted to the FDA
Correct answer: A scheduled review to ensure SOPs remain accurate, current, and reflective of actual practice
Periodic review ensures SOPs are reviewed at regular intervals (typically every 2-3 years) to verify they still reflect current practices, regulations, and equipment.
Question 6: In GxP record management, what is a 'quality record' versus a 'controlled document'?
- Quality records are completed forms documenting activities performed; controlled documents are instructions or procedures to be followed (Correct answer)
- Quality records are maintained by QA only; controlled documents are maintained by operations only
- Quality records require digital signatures; controlled documents require wet-ink signatures only
- Quality records are temporary working documents; controlled documents are permanent references
Correct answer: Quality records are completed forms documenting activities performed; controlled documents are instructions or procedures to be followed
Controlled documents (SOPs, protocols) prescribe what to do, while quality records (logbooks, batch records) are the completed evidence that activities were performed as required.
SQA SQA Documentation and Record Management 2
What is a 'deviation' in the context of GxP manufacturing documentation?