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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. What outcome is expected from conducting thorough APRs and PQRs?
Response:

A) Increase in employee productivity
B) Enhanced regulatory compliance and product quality
C) Identification of new markets
D) Reduction in manufacturing costs

2. Application of ICH Q9 helps in:
Response:

A) Identifying and controlling risks to product quality
B) Selecting marketing strategies
C) Determining the company's stock value
D) Designing product packaging

3. What are essential aspects to verify during the Installation Qualification (IQ) of new manufacturing equipment?
(Choose two)
Response:

A) That the equipment color matches the facility interior
B) That the equipment has been installed as per the manufacturer's recommendations
C) That the equipment is endorsed by celebrities
D) That the installation complies with design specifications

4. A critical component of supplier controls is:
Response:

A) The ability to influence supplier's internal management decisions
B) The documentation and agreement on quality specifications and delivery timelines
C) The establishment of a long-term partnership based on trust and mutual understanding
D) The reliance on verbal agreements to speed up the procurement process

5. Immediate actions in response to a trigger event should aim to:
Response:

A) Immediately resolve the underlying issue without investigation
B) Contain any potential impact
C) Assign blame to responsible parties
D) Eliminate the need for further action

Solutions:

Question # 1
Answer: B

Question # 2
Answer: A

Question # 3
Answer: B,D

Question # 4
Answer: B

Question # 5
Answer: B