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FAQs - Pharmaceutical GMP Professional Certification - CPGP

Common Questions about the CPGP

What value would the CPGP certification bring to candidates employed by companies in, or connected with, the pharmaceutical industry?

  • Preparing for and passing the CPGP exam greatly enhances the ability of a company’s GMP-following employees and management to raise the GMP compliance "bar" to a new level.
  • Supports internal continuous quality improvement programs.
  • It is sector-specific applied knowledge.

Which GMP regulations will the exam primarily focus on?

  • United States' FDA GMPs
  • European Union (EU) GMPs = PIC/S = TGA
  • World Health Organization (WHO) GMPs
  • Japanese GMPs
  • Canadian GMPs

Why would professionals in the following areas take this exam – change management/document control, logistics, manufacturing, quality control, technical service, validation, or research and development?

This certification demonstrates understanding and implementation of the principles underlying the laws, regulations, directives, standards, guidance, compendia for manufacturing, testing, and holding for finished pharmaceuticals and raw materials.

Is holding the CPGP certification the same as being an EU Qualified Person (QP)?

No. This exam has a different purpose and scope than that of the EU QP. All pharma job titles and all diverse backgrounds of people in terms of college majors can sit for and pass this exam. The QP is restricted to pharmacy and only a few other recognized majors, depending on the EU country. Also, this exam does not make someone legally responsible for batch release decisions, which is the realm of the QP.

Should candidates who work outside of strict pharmaceutical companies take this exam?

Yes. The industries connected to pharmaceuticals all have a stake in the ultimate drug product quality and GMP compliance. These industries include

  • Large, medium, and start-up innovator pharmaceutical companies
  • Generic drug manufacturers
  • API and other raw material manufacturers
  • Contract manufacturers and repackers
  • Labeling/packaging component suppliers
  • Pharmaceutical durable and disposable equipment suppliers
  • Critical pharmaceutical lab reagent suppliers
  • Pharmaceutical external service providers (contract metrology, engineering, validation, quality control test labs, consultants, etc.)

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