• Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Certification Provider: ASQ
  • Corresponding Certification:ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Packaging and Labeling Systems5%-9%- Packaging controls
  • 1. Label issuance and reconciliation
  • 2. Packaging inspections
  • 3. Tamper evidence
Topic 2: Facilities and Equipment Systems18%-22%- Equipment
  • 1. Qualification and validation
  • 2. Equipment cleaning
  • 3. Calibration and maintenance
- Facilities
  • 1. Facility design and maintenance
  • 2. Cleaning and sanitation
  • 3. Utilities and environmental controls
Topic 3: Materials Systems13%-17%- Material controls
  • 1. Storage and distribution
  • 2. Inventory control
  • 3. Incoming material inspection
  • 4. Supplier qualification
Topic 4: Laboratory Systems10%-14%- Laboratory operations
  • 1. Data integrity
  • 2. Analytical testing
  • 3. Microbiology controls
  • 4. Stability programs
Topic 5: Quality Management Systems22%-26%- Quality systems
  • 1. Documentation systems
  • 2. Quality culture
  • 3. Training systems
  • 4. GMP regulations and guidance
Topic 6: Production Systems23%-27%- Manufacturing operations
  • 1. Packaging and labeling
  • 2. Batch processing
  • 3. Process validation
  • 4. Contamination control

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

Which equipment qualification step verifies installation?

A. IQ
B. PQ
C. Validation review
D. OQ


Question 2

The process of _______ review involves evaluating test methods, qualifications, validation, and verification against required compendial chapters.
Response:

A. compendial or non-compendial requirements
B. administrative
C. personnel performance
D. financial


Question 3

What is the main purpose of assessing post-marketing changes in pharmaceuticals?
Response:

A. To adjust the product's market price
B. To evaluate their impact on safety and efficacy
C. To update marketing strategies
D. To redesign the product packaging


Question 4

How do retest dates differ from expiration dates on pharmaceutical materials?
Response:

A. Retest dates are only used for decorative purposes.
B. Retest dates indicate when a material should be re-evaluated for quality; expiration dates indicate when a material is no longer safe to use.
C. Expiration dates are suggestions, while retest dates are mandatory.
D. Retest dates and expiration dates are interchangeable terms.


Question 5

To ensure successful technology transfer, it's important to consider:
(Select two)
Response:

A. Social media marketing strategies
B. Shipping conditions
C. Branding guidelines
D. Hold times


Solutions:

Question 1
Answer: A
Question 2
Answer: A
Question 3
Answer: B
Question 4
Answer: B
Question 5
Answer: C,D

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