Question 1

How many CPGP practice questions are there?

Accepted Answer

110 questions across 1 version, each with the correct answer and an explanation.

Question 2

Are there free CPGP sample questions?

Accepted Answer

Yes. 12 sample questions are free; 6 are open to everyone and the rest unlock with a free account.

Question 3

What does full access include?

Accepted Answer

Every CPGP question in study, timed and flashcard modes, explanations for each answer, and progress that saves so you can resume.

Question 4

What topics does CPGP cover?

Accepted Answer

Regulatory Agency Governance (11.3%), Quality Systems (17.3%), Laboratory Systems (13.3%), Infrastructure: Facilities, Utilities, and Equipment (11.3%), Materials and Supply Chain Management (11.3%), Sterile and Nonsterile Manufacturing Systems (14.7%), Filling, Packaging, and Labeling (12%), Product Development and Technology Transfer (8.7%).

Question 5

What is the ASQ CPGP certification?

Accepted Answer

The ASQ Certified Pharmaceutical GMP Professional (CPGP) is a professional certification that validates a candidate's understanding and ability to apply good manufacturing practices (GMP) as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs, biologics, APIs, excipients, and packaging and labeling operations. The certification is offered by the American Society for Quality (ASQ) and demonstrates competency…

Question 6

How much does the CPGP exam cost?

Accepted Answer

The CPGP exam fee is $450 for ASQ members and $550 for non-members. Retake exams cost $350. ASQ membership provides a $100 discount on the initial examination fee. Additional costs may include the $130 rescheduling fee if you need to change your appointment. The exam is delivered through Prometric testing centers worldwide.

Question 7

What are the prerequisites for the CPGP certification?

Accepted Answer

To be eligible for the CPGP certification, candidates must have 5 years of on-the-job experience in one or more areas of the CPGP Body of Knowledge, with at least 3 of those years in a decision-making position. A decision-making position is defined as having the authority to define, execute, or control projects/processes and to be responsible for the outcome. There are no education waivers for this exam, and candidates must have worked in a full-time, paid role.

Question 8

Is the CPGP exam open book?

Accepted Answer

Yes, the CPGP exam is open book. Candidates may bring their own reference materials to the testing center. However, all reference materials (including notes) must be bound permanently by stitching or glue, or fastened securely in covers using ring binders, spiral binders, plastic snap binders, brads, or screw posts. Hand-stapled or loosely bound materials are not permitted. Post-It notes may be used as book tabs only and must be attached prior to entering the testing center.

Question 9

How many questions are on the CPGP exam?

Accepted Answer

The computer-based CPGP exam contains 165 multiple-choice questions, of which 150 are scored and 15 are unscored (pretest questions used for future exam development). The total exam time is 4 hours and 18 minutes (258 minutes), with a total appointment time of 4.5 hours (270 minutes). For paper-and-pencil delivery, the exam has 150 multiple-choice questions with a 4-hour time limit.

Question 10

What is the passing score for the CPGP exam?

Accepted Answer

The CPGP exam uses a scaled scoring system with a range of approximately 300-750 points. Candidates must achieve a score of 550 or higher out of 750 to pass. If you take the computer-based exam, you receive your result immediately after submission, with a confirmation email following within 3-5 business days. If you do not pass, you can retake the exam at a reduced rate of $350 within 2 years of your previous attempt.

Question 11

What topics does the CPGP exam cover?

Accepted Answer

The CPGP exam covers 8 major domains based on the 2023 Body of Knowledge: (1) Regulatory Agency Governance covering FDA, EMA, WHO, and other agencies (17 questions); (2) Quality Systems including QMS, CAPA, and change control (26 questions); (3) Laboratory Systems covering compendia, OOS investigations, and stability (20 questions); (4) Infrastructure: Facilities, Utilities, and Equipment (17 questions); (5) Materials and Supply Chain Management (17 questions); (6) Sterile and Nonsterile…

Question 12

Is the CPGP the same as being an EU Qualified Person?

Accepted Answer

No. The CPGP certification has a different purpose and scope than that of the EU Qualified Person (QP). The CPGP is open to all pharmaceutical job titles and diverse educational backgrounds, while the QP role is restricted to pharmacy and only a few other recognized majors depending on the EU country. Additionally, the CPGP does not confer legal responsibility for batch release decisions, which is the specific realm of the QP. The CPGP demonstrates broad GMP knowledge applicable across…

Question 13

How do I maintain my CPGP certification?

Accepted Answer

The CPGP certification is valid for 3 years. To maintain it, you must accumulate 30 Continuing Education Units (CEUs) during the validity period, submit a renewal application, and pay the renewal fee. CEUs can be earned through various professional development activities related to pharmaceutical GMP practice.

Question 14

Which industries benefit from CPGP certification?

Accepted Answer

The CPGP certification benefits professionals across a wide range of pharmaceutical-related industries including large, medium, and start-up innovator pharmaceutical companies; generic drug manufacturers; API and raw material manufacturers; contract manufacturers and repackers; labeling and packaging component suppliers; pharmaceutical equipment suppliers; critical pharmaceutical lab reagent suppliers; and pharmaceutical external service providers such as contract metrology, engineering,…

CPGPASQ Certified Pharmaceutical GMP Professional practice test

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Practice CPGP in the simulator.

CPGP, by the numbers.

Everything about CPGP.

Exam information

What CPGP covers

How do I earn this certification?

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Three ways to practise

Study mode

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CPGP questions, answered

CPGPASQ Certified Pharmaceutical GMP Professional practice test

Full access

Practice CPGP in the simulator.

CPGP, by the numbers.

Everything about CPGP.

Exam information

01Exam format258 min · 1655

02RegistrationPrometric, online proctoring2

03Validity3 years2

04In our question bankv1 (110)

What CPGP covers

01Regulatory Agency Governance11.3%7 topics

I.AGlobal regulatory frameworkIdentify the acts, statutes, and directives that apply to pharmaceuticals.1 obj.

I.BRegulations and guidancesInterpret frequently used regulations and guidelines/guidances/drafts including those published or administered by PIC/S, ICH, WHO, EMA, FDA, Health Canada, USDA 9CFR, and other national regulatory agencies and international standards (e.g. ISOs).1 obj.

I.CMutual recognition agreementsInterpret requirements that govern product registration, import or export of raw material or finished product, and the sharing of inspection findings.1 obj.

I.DRegulatory inspectionsDefine and describe various types of inspections including pre-approval, system-based, for-cause, and license renewal, and describe the frequency for each.2 obj.

I.EEnforcement actionsDefine and describe various global enforcement actions and consequences (e.g., warning letters, consent decree, license withdrawals, product seizure, and import alerts).1 obj.

I.FRegulatory agency reportingDescribe how post-marketing changes are assessed for impact to determine reporting method.6 obj.

I.GSite Master File (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)Describe the purpose and content of Site Master Files (SMFs), Validation Master Plans (VMPs), Drug Master Files (DMFs), and Site Reference Files (SRFs).1 obj.

Hands-on skills & common mistakesInterpreting GMP regulations · Confusing guidelines (non-binding) with regulations (binding)

02Quality Systems17.3%11 topics

03Laboratory Systems13.3%8 topics

04Infrastructure: Facilities, Utilities, and Equipment11.3%8 topics

05Materials and Supply Chain Management11.3%6 topics

06Sterile and Nonsterile Manufacturing Systems14.7%7 topics

07Filling, Packaging, and Labeling12%7 topics

08Product Development and Technology Transfer8.7%5 topics