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ASQ CPGP Exam Syllabus Topics:

Section	Objectives
Topic 1: Quality Control and Laboratory Systems	- Testing and release systems 1. Sampling and testing methodologies 2. Batch release and specification compliance
Topic 2: Documentation and Data Integrity	- GMP documentation practices 1. Data integrity principles (ALCOA+) 2. Batch records and SOP control
Topic 3: Production and Process Control	- Manufacturing operations 1. Process validation and control strategies 2. In-process controls and monitoring
Topic 4: 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 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: Validation and Qualification	- Validation lifecycle 1. Equipment qualification (IQ/OQ/PQ) 2. Process and cleaning validation

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

Staff performing inspections should:
Response:

A. Rely on manual checks on
B. Have frequent breaks from inspection
C. Focus on speed over accuracy
D. Avoid periodic eye examinations

Question 2

Configuration control in computerized systems ensures that:
Response:

A. All users have equal administrative access
B. System settings and versions are properly documented and controlled
C. Configuration changes are decided by popular vote among users
D. The system automatically updates without approval

Question 3

During a for-cause inspection, regulators focus on:
Response:

A. Evaluation of the company's market share and competitiveness.
B. Specific concerns or issues that have triggered the inspection.
C. Routine verification of compliance across all areas.
D. Long-term strategic planning for the company.

Question 4

Batch records must be reviewed for certain required elements. Which of the following is NOT one of these elements?
Response:

A. Proper issuance
B. Sections on yields
C. Critical manufacturing step verification
D. Employee vacation schedules

Question 5

PIC/S aims to harmonize inspection procedures worldwide. What does PIC/S stand for?
Response:

A. Pharmaceutical Inspection Convention/Cooperation Scheme
B. Pharmaceutical International Compliance/Security
C. Public Inspection Committee/Sector
D. Pharmaceutical Information Council/Standards

Solutions:

Question 1
Answer: B

Question 2
Answer: B

Question 3
Answer: B

Question 4
Answer: D

Question 5
Answer: A