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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q169-Q174):

NEW QUESTION # 169
Security requirements for computerized systems include all EXCEPT:
Response:

A. The ability to display high-definition videos
B. Data protection to safeguard sensitive information
C. Access control to prevent unauthorized use
D. Audit trails for tracking system changes

Answer: A

NEW QUESTION # 170
In relation to combination products, the studies required to meet GMP requirements often include:
Response:

A. Drug-device interaction studies
B. Consumer preference surveys
C. Long-term storage tests under various conditions
D. Financial impact assessments

Answer: A

NEW QUESTION # 171
Which of the following are reasons to update specifications?
(Choose two)
Response:

A. Annual change in management
B. Aesthetic preferences of the end-user
C. Change in regulatory requirements
D. Change in compendial methods

Answer: C,D

NEW QUESTION # 172
The main purpose of compendial methods review is to:
(Choose two)
Response:

A. Ensure methods are entertaining and engaging for laboratory staff.
B. Confirm methods are verified as suitable for specific testing applications.
C. Validate that methods meet regulatory and compendial requirements.
D. Determine the methods that require the least amount of reagents.

Answer: B,C

NEW QUESTION # 173
In inventory controls, what is the purpose of updating changes in material status?
Response:

A. To maintain operational efficiency and traceability of materials
B. To simplify the inventory process
C. To ensure accurate financial reporting
D. To reduce the space needed for storage

Answer: A

NEW QUESTION # 174
......

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