GMP Training Quiz
Questions: 16 · 10 minutes
1. A container in a staging area has no clear identity or status label. What should an employee do?
Use it if its appearance matches the material listed in the record
Do not use it; segregate or report it according to the approved procedure
Ask a coworker to identify it and add a handwritten name
Return it to general storage for another team to evaluate
2. What is the primary purpose of Good Manufacturing Practice in a regulated manufacturing environment?
To ensure products are consistently produced and controlled to appropriate quality standards
To eliminate the need for finished-product testing
To maximize production speed by standardizing operator movements
To allow each department to define quality independently
3. An operator discovers a torn glove while handling exposed product. What is the best GMP response?
Finish the current step, then replace the glove before the next batch
Put a second glove over the torn one without interrupting the task
Stop appropriately, protect the product, replace the glove, and report the potential contamination as required
Continue if the operator did not directly see the glove touch the product
4. Which documentation practice best reflects the principle that GMP records should be contemporaneous?
Using a separate notebook and transferring selected details later
Completing all routine entries from memory at the end of the week
Entering planned completion times before the work begins
Recording an activity when it is performed or immediately afterward
5. Two approved lots of the same material are available and both have acceptable status. Unless an approved instruction says otherwise, which lot should generally be selected first?
The lot stored closest to the production area
The lot with the earlier expiry or retest date
The lot with the largest remaining quantity
The lot received from the most frequently used supplier
6. Several employees share one login for an electronic production system. Why is this a GMP data-integrity concern?
Shared accounts prevent the system from calculating production totals
Shared accounts always make electronic records legally invalid
Shared accounts stop supervisors from reviewing completed records
Shared credentials can prevent actions from being reliably attributed to the person who performed them
7. While completing a paper batch record, an operator notices that they entered the wrong equipment number. What is the most appropriate correction?
Erase the number completely and enter the correct one
Start an unofficial replacement page and discard the original
Leave the error and explain it verbally at the end of the shift
Correct it according to the approved documentation procedure while preserving the original entry
8. A laboratory result falls outside its established specification. Which response is most appropriate?
Preserve the original data and follow the approved out-of-specification investigation procedure
Average the result with previous passing results from the same product
Discard the result if the analyst suspects a preparation error
Repeat the test until an acceptable result is obtained, then report that result
9. During processing, the physical quantity of material does not match the quantity recorded in the batch record. What should the operator do first?
Replace the recorded value with the physical count
Stop as appropriate, preserve the information, and report the discrepancy under the approved procedure
Continue processing and quarantine the product after completion
Adjust the quantity if the difference appears too small to affect the batch
10. A packaging line is about to begin a different product. Which action best reduces the risk of a product or label mix-up?
Run the first few units slowly and inspect them later
Keep leftover components nearby in case the next batch needs them
Perform and document the required line clearance before starting
Rely on the new batch paperwork to distinguish the products
11. After cleaning a piece of production equipment, what documentation action most closely follows GMP expectations?
Record only that the equipment is ready for production
Wait until the next product is started to confirm that cleaning occurred
Complete the approved cleaning record promptly with the actual required details
Keep a personal checklist and update the official record at the end of the month
12. A customer reports an unexpected defect in a distributed product. What is the appropriate GMP approach?
Wait for several similar reports before creating a formal record
Document and route the complaint for timely evaluation and investigation under the quality system
Replace the product and close the matter if the customer is satisfied
Send the report only to the production operator who made the batch
13. A team wants to change a validated process parameter to improve output. What should happen before the change is routinely implemented?
The operator should note the new value in the batch record as a temporary preference
The team should try it during production and document it only if output improves
The proposal should be assessed and approved through the applicable change-control process
The change should proceed if it remains within the equipment’s mechanical capability
14. Before performing a routine manufacturing task, which instruction should an employee follow?
The current approved procedure available through the controlled system
A personal copy saved before the latest document revision
The method remembered from the employee’s initial training
A draft revision that is expected to be approved soon
15. At the end of a packaging run, the issued and returned label counts do not reconcile. What is the most appropriate action?
Halt closure or release activities as required and investigate the discrepancy through the approved process
Close the record if all packaged units appear correct
Carry the difference into the reconciliation for the next batch
Estimate the missing quantity based on normal line waste
16. A trained employee is assigned a task they have observed but have never been qualified to perform. What should they do?
Perform it alone if a qualified coworker is available by phone
Begin the task and request retrospective training afterward
Use the completed record from a previous batch as the main instruction
Explain the training gap and obtain the required instruction or authorization before proceeding