The Certified GMP Production Operations Professional/Manager (CGMPOP)™/(CGMPOM)™ certification program is a prestigious and industry-recognized qualification designed for professionals aiming to excel in production environments governed by Good Manufacturing Practices (GMP). In industries such as pharmaceuticals, biotechnology, cosmetics, medical devices, and food processing, GMP compliance is a critical operational requirement to ensure product safety, quality, and regulatory adherence. This program provides participants with in-depth expertise in GMP principles, production workflow management, quality assurance, documentation standards, and continuous improvement strategies within a regulated manufacturing setting.
GMP production operations involve more than just running a production line—they require meticulous adherence to documented procedures, rigorous quality control measures, thorough staff training, and consistent process monitoring. Participants will explore topics such as production planning, cleanroom and controlled environment operations, process validation, regulatory inspections, risk-based approaches to compliance, and the integration of automation and digital monitoring tools. The curriculum emphasizes operational excellence while ensuring full regulatory compliance with agencies such as the FDA, EMA, WHO, and other global authorities.
Whether working in a large-scale manufacturing facility, a contract manufacturing organization (CMO), or a niche specialty production unit, graduates of the CGMPOP™/CGMPOM™ program will be equipped to manage production operations that meet the highest international standards for safety, quality, and efficiency.
Certification Program Objectives:
Upon completing the Certified GMP Production Operations Professional/Manager (CGMPOP)™/(CGMPOM)™ program, participants will be able to:
- Understand GMP Fundamentals and Regulatory Requirements – Gain a comprehensive understanding of Good Manufacturing Practices and compliance frameworks.
- Manage Production Workflows Efficiently – Oversee end-to-end production processes while ensuring adherence to GMP protocols.
- Implement Quality Control and Assurance Systems – Maintain product integrity through inspection, testing, and documentation.
- Optimize Resources and Reduce Waste – Apply lean manufacturing principles within a GMP environment.
- Leverage Technology for Compliance and Efficiency – Use automation, monitoring systems, and data analytics to enhance production oversight.
- Prepare for and Manage Regulatory Audits – Ensure readiness for inspections from national and international regulatory bodies.
Certification Eligibility Criteria:
To apply for certification from The Operations Management Institute (OMI), candidates must meet the following criteria:
- A Bachelor’s degree from a recognized institution
And/or
- 0–4.9 years relevant experience for Professional level (CGMPOP)™, or 5+ years for Manager level (CGMPOM)™.
Note: Applicants who do not hold a Bachelor’s degree but possess exceptional professional experience and hold significant positions within their organizations in a relevant field may also be considered for certification on a case-by-case basis, subject to the approval of the OMI evaluation committee.
Certifying Examination:
- To be certified as CGMPOP™/CGMPOM™, student should take up a 1.5 hours online exam conducted by OMI.
- The qualifying exam would consist of 50 multiple choice questions, testing core certification modules.
- Professionals with relevant experience and other qualifying criteria may be exempted from the examination.
Certification Modules:
- Module 1: Fundamentals of Good Manufacturing Practices (GMP)
- Module 2: Production Planning, Scheduling, and Workflow Management
- Module 3: Quality Assurance, Quality Control, and Documentation Standards
- Module 4: Cleanroom Operations, Hygiene, and Contamination Control
- Module 5: Automation, Monitoring, and Data Integrity in GMP Environments
- Module 6: Regulatory Compliance, Audits, and Continuous Improvement
* The Certification Title and its modules are regularly reviewed, updated and may change in alignment with evolving industry needs and regulatory standards.
Who Should Do This Certification:
The CGMPOP™/CGMPOM™ certification is ideal for professionals involved in or aspiring to manage GMP-compliant production operations, including:
- Production Supervisors and Managers – Leading day-to-day manufacturing in regulated industries.
- Quality Assurance and Quality Control Professionals – Ensuring product quality and compliance.
- Regulatory Affairs Specialists – Overseeing adherence to GMP requirements.
- Process Engineers and Technicians – Designing and maintaining compliant production systems.
- Manufacturing Operations Leaders – Driving efficiency while maintaining strict compliance.
- Consultants and Advisors – Offering compliance and operational improvement solutions to regulated manufacturers.
Key Benefits of CGMPOP / CGMPOM Certification:
- Professional Recognition – Establishes you as a GMP production operations expert.
- Career Growth – Opens advancement opportunities in regulated manufacturing sectors.
- Global Relevance – Skills applicable in pharmaceutical, biotech, food, and other GMP-governed industries worldwide.
- Practical Learning – Gain tools to solve real-world compliance and operational challenges.
- Professional Network – Connect with a global community of GMP and manufacturing professionals.
- Measurable Impact – Enhance production efficiency, ensure product safety, and maintain compliance.
- Best Practice Alignment – Based on internationally recognized GMP standards and operational excellence frameworks.
The CGMPOP™/CGMPOM™ certification empowers professionals to lead production operations that uphold the highest standards of quality, safety, and regulatory compliance. Whether your goal is to improve operational efficiency, pass regulatory inspections with confidence, or advance in a regulated manufacturing career, this program provides the knowledge and credentials to excel.
