ASQ CPGP Certification Exam Sample Questions

CPGP Dumps PDF, Pharmaceutical GMP Professional Dumps, download Pharmaceutical GMP Professional free Dumps, ASQ Pharmaceutical GMP Professional exam questions, free online Pharmaceutical GMP Professional exam questionsYou have to pass the CPGP exam to receive the certification from ASQ. To increase the effectiveness of your study and make you familiar with the actual exam pattern, we have prepared this ASQ Pharmaceutical GMP Professional sample questions. Our Sample ASQ Certified Pharmaceutical GMP Professional Practice Exam will give you more insight about both the type and the difficulty level of the questions on the ASQ Pharmaceutical GMP Professional exam.

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ASQ Pharmaceutical GMP Professional Sample Questions:

01. A biologic labeled for storage at 2–8 °C arrives with an in-transit data logger showing a brief excursion above the upper limit during transport.
What is the most appropriate first action?
a) Place the shipment in quarantine and evaluate the excursion against the product's established stability and temperature-excursion data before disposition.
b) Accept the shipment on the basis that the excursion was brief, assuming a short duration is safe without consulting stability data.
c) Accept and release the shipment straight to stock, treating the in-transit logger reading as only advisory information.
d) Reject and destroy the shipment immediately, treating any brief excursion above the labeled range as automatically making the biologic permanently unusable.
 
02. A company outsources production of an established topical cream to an external contract manufacturer at a different site; the sending unit retains ownership of the product and marketing authorization while the receiving unit will perform routine commercial manufacture.
This arrangement is best described as which type of technology transfer?
a) A compendial analytical method transfer involving only laboratory test procedures, with no commercial manufacturing element
b) A development-to-commercial (R&D-to-operations) internal transfer occurring entirely within a single organization's own manufacturing sites
c) A salvage-and-rework disposition of returned finished goods handled under a deviation and reprocessing procedure
d) A transfer to an external contract manufacturer, governed by a quality agreement defining GMP responsibilities between the parties
 
03. A firm is defining which post-market situations require prompt or expedited reporting to the regulator, as opposed to routine periodic reporting.
Which situations typically warrant expedited reporting?
(Choose two.)
a) A confirmed significant product-quality defect that could adversely affect patient safety.
b) Routine periodic trending of normal in-specification test results across production.
c) deviation
d) A distributed lot found to present a potential significant safety hazard to product users.
e) A planned change already assessed and documented as having no product impact.
 
04. A sponsor outsources sterile fill-finish of a biologic to a contract manufacturing organization (CMO). Legal is preparing the commercial supply contract; the quality units of both firms are asked what the accompanying quality agreement must establish.
What does the quality agreement principally define?
a) The marketing positioning and permissible labeling and promotional claims the sponsor may make about the finished biologic once it is released.
b) The specific GMP roles, responsibilities, and decision rights of each party, including who controls change, deviation handling, and batch disposition.
c) The per-batch pricing, minimum volume commitments, delivery schedule, and payment and penalty terms for the outsourced fill-finish batches.
d) The intellectual-property ownership of the biologic's manufacturing process, master cell line, and any process improvements developed during the engagement.
 
05. An environmental monitoring trend in a controlled non-sterile area shows a slow rise in fungal isolates, and the facility currently uses one routine disinfectant.
Which practice best strengthens the sanitization program?
a) Replace chemical disinfection entirely with more frequent dry dusting and dry wiping of the room surfaces.
b) Increase the single existing disinfectant's concentration well beyond its validated in-use dilution to overpower the fungal isolates.
c) Incorporate periodic use of a sporicidal agent and rotate disinfectants so resistant organisms are addressed.
d) Stop the routine environmental monitoring program so the rising fungal trend no longer appears in the data.
 
06. An incubated media fill yields one or more contaminated (turbid) units. The site must respond to this aseptic process simulation failure.
Select the appropriate elements of the response to a failed media fill.
(Choose three.)
a) Conduct a thorough investigation to identify the probable root cause of the contamination.
b) Identify and implement corrective actions, then successfully repeat the simulation to confirm control before resuming.
c) Delete the failing turbid units from the incubation record so that the overall media-fill run is recorded as a pass.
d) Automatically release the represented product, on the basis that a single contaminated unit is statistically meaningless and can be disregarded.
e) Assess the impact on the sterility assurance of product made under the represented conditions.
 
07. An excipient shipment arrives at the warehouse. Receiving personnel find the container labels legible and the CoA present, but one drum's outer tamper seal is broken and its lid is slightly ajar.
What is the appropriate handling of this receipt under GMP?
a) Reject and return the entire shipment to the supplier straight from the receiving dock without recording a deviation or opening an investigation.
b) Sample every drum for identity only and, once identity passes, release the full lot including the open, potentially contaminated affected drum.
c) Assign the whole lot quarantine status and open a documented deviation for the compromised drum before any material is sampled or released.
d) Release the intact drums to production immediately and place only the drum with the broken seal on hold for a later integrity review.
 
08. An operator makes a wrong entry in a bound GMP batch record and asks a supervisor how to correct it under good documentation practices.
Which correction method is compliant?
a) Draw a single line through the error so it remains legible, write the correct entry, and add initials, date, and a reason for the change.
b) Leave the wrong entry untouched and note the correct value on a separate loose sheet that is kept in a nearby drawer for later reference.
c) Erase the incorrect entry down to blank paper and rewrite the correct value in its place so the record looks clean and error-free for the reviewer.
d) Use white correction fluid to fully cover the erroneous entry, then write the correct value on top once the fluid has dried so the batch record reads cleanly.
 
09. During an inspection, a firm argues it need not meet a particular binding requirement because a regulatory guidance document describes an alternative, less burdensome approach.
How should the relationship between the regulation and the guidance be analyzed?
a) Regulations and guidance documents carry exactly equal legal force and are equally binding and directly enforceable on the firm during any routine inspection.
b) Guidance always overrides a regulation whenever the guidance document is the more recently issued of the two.
c) Because the guidance is non-binding, the underlying regulation it discusses is effectively optional as well.
d) Regulations are legally binding requirements, while guidance reflects current thinking and acceptable approaches and cannot override a binding requirement.
 
10. At the end of a bottle-labeling run, the label reconciliation shows: issued 12,000 labels, applied to good bottles 11,120, damaged/rejected labels destroyed 300, and returned to stores 400.
What is the most appropriate quality action for the packaging supervisor?
a) Treat the 180-label shortfall as an unexplained discrepancy and open an investigation before releasing the lot
b) Destroy the 400 good returned labels so the issued-versus-consumed balance closes more simply
c) Post the missing labels back to inventory as a routine stores adjustment so the issued balance agrees
d) Release the lot because a reconciliation gap within a few hundred labels reflects normal application and waste process loss

Answers:

Question: 01
Answer: a		 Question: 02
Answer: d		 Question: 03
Answer: a, d		 Question: 04
Answer: b		 Question: 05
Answer: c
Question: 06
Answer: b, e		 Question: 07
Answer: c		 Question: 08
Answer: a		 Question: 09
Answer: d		 Question: 10
Answer: a

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