Certified Pharmaceutical GMP Professional (CPGP) Exam

Carefully Crafted Practice Questions | Certdemy

Last Updated: June 2024

Certified Pharmaceutical GMP Professional (CPGP) Exam Topics Cover:

Definition and purpose of GMP in pharmaceutical manufacturing.
Historical background and evolution of GMP regulations.
Regulatory agencies and their roles (FDA, EMA, WHO, etc.).
Importance of GMP in ensuring product quality, safety, and efficacy.
Regulatory Framework:
Overview of relevant regulations and guidelines (e.g., FDA CFR 21 Part 210/211, EU GMP Guidelines).
Understanding the structure and content of GMP regulations.
Interpretation and application of regulatory requirements in pharmaceutical manufacturing.
Quality Management Systems (QMS):
Principles of quality management and quality assurance.
Components of a QMS (document control, change control, deviation management, CAPA).
Risk management and its integration into QMS.
Internal and external audits.
Documentation and Records Management:
Documentation requirements in pharmaceutical GMP.
Documentation practices (batch records, SOPs, validation protocols, reports).
Recordkeeping principles and practices.
Data integrity and compliance with ALCOA+ principles.
Good Documentation Practices (GDP):
Importance of GDP in maintaining data integrity and traceability.
Requirements for accurate and complete documentation.
Common pitfalls and best practices in documentation.
Facility and Equipment Design:
Facility design and layout considerations for GMP compliance.
Cleanroom classifications and requirements.
Equipment qualification (IQ, OQ, PQ) and calibration.
Preventive maintenance and calibration programs.
Personnel Training and Hygiene:
Training requirements for GMP personnel.
Gowning procedures and personnel hygiene practices.
Contamination control measures.
Behavior-based safety practices.
Material Management:
Raw material qualification and vendor management.
Handling, storage, and distribution of materials.
Labeling and packaging requirements.
Good Distribution Practices (GDP).
Production and Process Controls:
Batch record review and approval.
In-process controls and monitoring.
Process validation principles and practices.
Change control procedures for production processes.
Quality Control and Testing:
Sampling techniques and sampling plans.
Analytical testing methods and validation.
Stability testing and shelf-life determination.
Out-of-specification (OOS) and out-of-trend (OOT) investigations.
Compliance and Inspections:
Preparation for regulatory inspections.
Responding to inspection findings and observations.
Corrective and preventive action (CAPA) management.
Regulatory trends and updates.
Risk Assessment and Management:
Principles of risk assessment and risk management.
Application of risk assessment tools (FMEA, HACCP) in pharmaceutical manufacturing.
Risk-based decision-making in GMP processes.
Continuous Improvement:
Principles of Lean manufacturing and Six Sigma.
Continuous improvement methodologies and tools.
Implementation of Kaizen and process optimization.
Ethics and Professionalism:
Ethical considerations in pharmaceutical manufacturing.
Professional conduct and integrity.
Confidentiality and data security.
Emerging Trends and Technologies:
Industry 4.0 and digital transformation in pharmaceutical manufacturing.
Advanced manufacturing technologies (e.g., continuous manufacturing, PAT).
Regulatory implications of emerging technologies.

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