GMP Certification FAQ
How was the GMPC Program Developed?
GMPC was born out of the needs of you and your peers. In working with thousands of industry professionals, a need to recognize GMP expertise was identified. As a result, the unique union of subject matter experts and years of PTi industry research was formed to develop a GMP examination.
Upon reviewing the examination, senior executives from the top five pharmaceutical companies collectively agreed that it is a much needed analysis of a person's GMP aptitude. Special thanks go out to these executives and subject matter experts.
Additionally, a review of the examination was conducted by a Consumer Safety Officer in the Division of Manufacturing and Product Quality, Office of Compliance, CDER. The examination was found to accurately test the good manufacturing practices (GMPs) as represented in 21 CFR 211. It was noted that the examination should be helpful to the industry given its content*.
What does the GMPC Examination Involve?
To achieve GMPC, you must pass a rigorous initial examination. Beginning March 1, 2006, the examination will be available online. Through a series of 100 multiple choice questions, it is designed to assess your knowledge and skills in critical GMP areas:
-Production and Process Controls -Laboratory Testing
-Packaging and Labeling Controls -Buildings and Facilities
-Records and Reports -Equipment
-Returned and Salvaged Drug Products -Organization and Personnel Responsibilities
-Laboratory Controls -Control of Component and Drug Product
Containers and Closures
How do I Maintain My GMPC?
GMPC is designed to display your continuing commitment to GMP excellence. As a result, during the three year period following your successful completion of the examination, you're required to obtain recertification points. Points can be accumulated through a number of learning activities, including authoring articles in approved publications, attending continuing education seminars or serving on the boards of approved associations.
Who can Take the Examination?
While there are no formal prerequisites for taking the examination, applicants should have a strong knowledge of GMP regulations. Experience in a professional manufacturing setting is strongly recommended.
How can I Prepare for the Examination?
A full line of GMP training courses and additional resources are available to help prepare you for the examination. Some of the most popular include:
- Introduction to Good Manufacturing Practices
- Complying with cGMP and GMP Requirements – Advanced Level
What Do I Receive Once I Pass the Examination?
After you have successfully passed the examination, you will receive a certificate that endorses your GMP excellence, and you will be granted the title of GMPC.
How Much Does the Examination Cost?
The cost for the opportunity to become GMPC Certified is $395.
What's My Next Step?
Interested in advancing your career and distinguishing yourself from the field by acquiring GMPC? Call PTi today to sign up for the exam - (646) 895 7447.
*PTi and all industry professionals taking the examination should recognize that this examination is NOT FDA endorsed or approved, and it not an agency standard, official document or guidance.