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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Documentation and Data Integrity | - GMP documentation practices
|
| Topic 2: Validation and Qualification | - Validation lifecycle
|
| Topic 3: Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Topic 4: Quality Control and Laboratory Systems | - Testing and release systems
|
| Topic 5: GMP Regulations and Compliance | - Inspection readiness
|
| Topic 6: Production and Process Control | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The validation of automated or computerized systems should ensure that:
Response:
- A. Systems require minimal to no maintenance over their operational life
- B. Systems are capable of posting updates to social media automatically
- C. Critical parameters are identified, controlled, and monitored
- D. Systems are resistant to any form of cyber-attack, even hypothetical future threats
Correct Answer: C 🗳️
The appropriate storage of samples and reagents is essential to:
Response:
- A. Minimize the space used in the laboratory
- B. Maintain the material's characteristics for accurate testing
- C. Make it easier to dispose of after use
- D. Enhance the appearance of the laboratory
Correct Answer: B 🗳️
A pre-approval inspection in the pharmaceutical industry is conducted to:
Response:
- A. Investigate a specific complaint or adverse event.
- B. Confirm the effectiveness of a new marketing strategy.
- C. Evaluate the overall financial health of the manufacturing firm.
- D. Assess the manufacturing site's compliance with regulatory standards before product approval.
Correct Answer: D 🗳️
The adequacy of controls over procurement from suppliers is assessed to:
Response:
- A. Determine if the supplier can host impressive business dinners
- B. Influence the supplier's operational decisions
- C. Ensure the reliability and quality of raw materials, components, and services
- D. Promote the supplier's products over competitors
Correct Answer: C 🗳️
ICH Q12's focus on product lifecycle management implies that risk management:
Response:
- A. Ends once the product is launched
- B. Is a one-time activity
- C. Needs constant updating and application
- D. Is only relevant for new products
Correct Answer: C 🗳️
