CERTIFIED PHARMACEUTICAL GMP PROFESSIONAL CPGP

WHY BECOME A CERTIFIED

PHARMACEUTICAL GMP PROFESSIONAL?
As a Certified Pharmaceutical GMP Professional (CPGP) you will understand Good Manufacturing
Practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical
industry. This certification is applicable for all industries connected to pharmaceuticals that have a stake in
the ultimate drug product quality and GMP compliance. These industries include generic drug manufacturers;
pharmaceutical, durable, and disposable equipment suppliers; pharmaceutical lab reagent suppliers; and
pharmaceutical external service providers, contract metrology, engineering, validation, quality control test
labs, consultants, etc.

What New Skills and Techniques Will You Learn?

• A fundamental understanding of regulatory agency • Sampling plans and procedures for shipping
governance including global regulatory frameworks, and receiving materials; analysis of in-house
relevant regulations and guidelines, and mutual storage, identification, and rotation of materials;
recognition agreements. and requirements for materials’ traceability and
sourcing, including returned goods.
• The elements and requirements of a quality system,
various types of audits and self-inspections, and • Sterile and nonsterile manufacturing systems,
record management systems. analysis of master and completed batch
records, material control procedures,
• Factors relating to laboratory systems, including
and contamination controls.
relevant compendia for United States, Europe, and
Japan; investigations of aberrant laboratory results; • Product design factors, phase-appropriate
and instrument control and record-keeping. GMP requirements, filling and packaging
operations and controls, and analysis of
• Requirements and specifications for construction of
technology transfer activities.
facilities, utilities, and equipment; evaluation of automated
or computerized systems; and application of business
continuity plans and disaster recovery techniques.

What Is the Value to Your Company? What Is the Value to You?

• Good manufacturing practices (GMPs) ensure that • Improved knowledge, skills, and abilities qualify
pharmaceutical products are safe, efficacious, and you for more positions within modern business
pure. Employees who have obtained certification industries that require demonstrated competency
as a Pharmaceutical GMP Professional have a in pharmaceutical GMPs.
demonstrated, extensive, and proven knowledge
• CPGPs with a job title of manager make an
of the quality system, ensuring that high-quality
average salary of $105k per year; compared
products are delivered to the consumer. With their
to those without certification, who make
breadth of knowledge, employees holding a CPGP
approximately $93k (national average).*
can support nearly any aspect of your company’s
business and deliver exceptional performance.
*Please see the current Quality Progress Salary Survey at:
asq.org/qualityprogress/ under Tools and Resources.
CERTIFIED PHARMACEUTICAL GMP PROFESSIONAL CPGP
Qualifications and Requirements Pharmaceutical GMP Professional Learning
for CPGP Certification Resources and Certification Preparation
Candidates must have five years of on-the-job • Pharmaceutical GMP Professional Certification
experience in one or more of the areas of the Preparation Training (on-site and online learning
Certified Pharmaceutical GMP Professional Body provided by ASQ)
of Knowledge. A minimum of three years of this
• The Certified Pharmaceutical GMP Professional
experience must be in a decision-making position.
Handbook, Second Edition
“Decision-making” is defined as the authority to
define, execute, or control projects/processes and • Statistical Process Control for the FDA-Regulated Industry
to be responsible for the outcome. This may or may
not include management or supervisory positions.
Recertification Required?
Yes, every three years.
Education
There are no education waivers for this exam.
How to Enroll for Certification
Visit asq.org/cert

MARKETPLACE INFORMATION
COMMON JOB FUNCTIONS COMMON INDUSTRIES
Auditor Government
Inspector Medical Device
Manager Packaging
Quality Assurance Pharmaceutical Manufacturing
Supervisor Service
Technician

Key Market Trends

• The industry is expected to register growth • The industry is engaged in discovery,
led by an aging population, changing lifestyles, development, manufacture, and marketing
hectic daily activities, unhealthy eating habits, of prescription drugs. Industry products
and an increasing incidence of chronic diseases include ethical drugs and consumer healthcare.
across the entire global population, providing
growth opportunities for industry players.