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ASQ CPGP Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Packaging and Labeling Systems	5%-9%	- Packaging controls 1. Tamper evidence 2. Label issuance and reconciliation 3. Packaging inspections
Topic 2: Laboratory Systems	10%-14%	- Laboratory operations 1. Analytical testing 2. Data integrity 3. Stability programs 4. Microbiology controls
Topic 3: Materials Systems	13%-17%	- Material controls 1. Incoming material inspection 2. Supplier qualification 3. Inventory control 4. Storage and distribution
Topic 4: Facilities and Equipment Systems	18%-22%	- Facilities 1. Facility design and maintenance 2. Cleaning and sanitation 3. Utilities and environmental controls - Equipment 1. Qualification and validation 2. Equipment cleaning 3. Calibration and maintenance
Topic 5: Quality Management Systems	22%-26%	- Quality systems 1. GMP regulations and guidance 2. Training systems 3. Quality culture 4. Documentation systems
Topic 6: Production Systems	23%-27%	- Manufacturing operations 1. Contamination control 2. Process validation 3. Batch processing 4. Packaging and labeling

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q108-Q113):

NEW QUESTION # 108
Compliance with compendial requirements is essential for:
Response:

A. Meeting legal and regulatory requirements.
B. Increasing laboratory profitability.
C. Ensuring rapid testing processes.
D. Simplifying laboratory procedures.

Answer: A

NEW QUESTION # 109
When an adverse event report involves a counterfeit product, the company should:
Response:

A. Ignore the report, as it does not involve a genuine product.
B. Only inform the direct customers about the counterfeit product.
C. Inform regulatory authorities and possibly issue a public warning to prevent further harm.
D. Consider the event as a minor issue that does not require action.

Answer: C

NEW QUESTION # 110
Evidence of printed material reconciliation is required to:
Response:

A. Justify budget increases
B. Monitor employee performance
C. Ensure correct material usage and account for discrepancies
D. Track the number of breaks taken by employees

Answer: C

NEW QUESTION # 111
Which of the following statements about sanitization and protection in manufacturing is true?
Response:

A. Only required for liquid products
B. Essential for maintaining product quality and safety
C. Not necessary for solid dosage forms
D. Only applies to nonsterile manufacturing environments

Answer: B

NEW QUESTION # 112
The primary purpose of supplier audits is to:

A. Evaluate marketing capability
B. Check financial status
C. Reduce cost
D. Monitor supplier compliance and quality

Answer: D

NEW QUESTION # 113
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