About:
The Certified Pharmaceutical GMP Professional (CPGP®) certification validates expertise in Good Manufacturing Practices (GMP) as regulated by national and international agencies. It ensures proficiency in compliance, quality assurance, and regulatory requirements within the pharmaceutical industry, covering human and veterinary drugs, biologics, dietary supplements, and related materials.
Certification body: American Society for Quality (ASQ®)
Learning objective:
- Gain in-depth knowledge of GMP regulations and compliance.
- Develop expertise in quality systems, laboratory controls, and manufacturing practices.
- Understand regulatory requirements for pharmaceuticals, including active pharmaceutical ingredients (APIs), excipients, packaging, and labeling.
- Enhance skills in auditing, process control, and risk management.
Exam information:
- Format: Multiple-choice, open-book exam.
- Computer-Based Test (CBT): 165 questions (150 scored, 15 unscored), 4.5-hour total duration.
- Paper-Based Test: 150 questions, 4-hour total duration.
- Language: English.
- Results: Immediate for CBT; official confirmation within 3-5 business days.
- Re-exam Policy: Candidates can reapply within two years at a reduced rate.
Recertification:
- Required every three years.
- Maintain certification through professional development activities or by retaking the exam.
- Ensures continuous expertise in GMP compliance and evolving regulatory standards.
Eligibility:
- Minimum of 5 years of work experience in GMP-related fields.
- At least 3 years must be in a decision-making role.
- Full-time, paid work experience is mandatory.
- No education waivers available.
Target audience:
- Pharmaceutical quality auditors and compliance professionals.
- Regulatory affairs specialists.
- Quality assurance managers and consultants.
- Manufacturing and production professionals in GMP environments.
- Professionals seeking career advancement in the pharmaceutical industry.
Curriculum:
- Regulatory Agency Governance
- Quality Systems
- Laboratory Systems
- Infrastructure: Facilities, Utilities, and Equipment
- Materials and Supply Chain Management
- Sterile and Nonsterile Manufacturing Systems
- Filling, Packaging, and Labeling
- Product Development and Technology Transfer
