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ASQ CPGP Exam Syllabus Topics:

Section	Objectives
Topic 1: Production and Process Control	- Manufacturing operations 1. In-process controls and monitoring 2. Process validation and control strategies
Topic 2: Validation and Qualification	- Validation lifecycle 1. Process and cleaning validation 2. Equipment qualification (IQ/OQ/PQ)
Topic 3: GMP Regulations and Compliance	- Regulatory frameworks 1. FDA cGMP requirements 2. ICH guidelines overview - Inspection readiness 1. Audit preparation and response 2. Regulatory inspection process
Topic 4: Quality Control and Laboratory Systems	- Testing and release systems 1. Sampling and testing methodologies 2. Batch release and specification compliance
Topic 5: Pharmaceutical Quality Systems	- Quality system principles and implementation 1. Continuous improvement and quality metrics 2. Quality management system structure in pharma GMP environments
Topic 6: Documentation and Data Integrity	- GMP documentation practices 1. Data integrity principles (ALCOA+) 2. Batch records and SOP control

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Data archiving in computerized systems is critical for:
Response:

A) Storing an unlimited amount of irrelevant data
B) Ensuring long-term data retrieval and compliance with regulatory requirements
C) Archiving all emails and communications for entertainment purposes
D) Keeping a historical record of the company's social events

2. A corrective action in response to a product complaint may include:
Response:

A) Increasing the price of the product to improve its perceived value.
B) Issuing a public apology on social media.
C) Discontinuing all marketing activities for the product.
D) Modifying the product design or formulation.

3. Revalidation of processes is NOT typically required when:Response:

A) There are significant changes to the process
B) New equipment is introduced
C) The product design is slightly altered for marketing purposes
D) Regulatory guidelines change

4. For combination products, GMP requirements include:
Response:

A) Treating the product as a simple drug formulation
B) Studies specific to drug-device interactions
C) Ignoring device components
D) Excluding usability studies

5. Which of the following best describes the purpose of the GMP document system in a pharmaceutical manufacturing environment?
Response:

A) To document compliance with regulatory and corporate standards.
B) To monitor the stock levels of raw materials.
C) To manage employee schedules and attendance.
D) To ensure efficient production schedules.

Solutions:

Question # 1
Answer: B

Question # 2
Answer: D

Question # 3
Answer: C

Question # 4
Answer: B

Question # 5
Answer: A