New GMP Professional Exam Offered

January 29, 2009
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals.

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals. The exam is meant to certify intermediate-to-advanced pharmaceutical industry professionals with at least five years experience interpreting and practicing GMP compliance.

Professionals in the following pharmaceutical areas may be interested in taking the exam: change control, engineering and maintenance, GMP-relevant research and development, operations, quality control, quality assurance, compliance, auditing, supply chain management, validation, and technology transfer.

The key benefits of obtaining the certification, according to Robert Seltzer, founder of the new exam and GMP compliance manager at Schering-Plough (Berkeley Heights, NJ), are: 

  • To enable companies to raise their GMP-compliance “bar” to a higher level

  • To support internal company programs of continuous quality improvement

  • To have sector-specific applied knowledge

  • To gain professional and personal pride

  • To enhance a professional’s credibility and standing with outside business partners.

Although regulatory bodies such as the US Food and Drug Administration do not officially endorse industry-based certification or training programs, says Seltzer, a number of groups now offer them. The International Society for Pharmaceutical Engineers (ISPE), PTi International, the Center for Professional Education and Innovation, and the New Jersey Pharmaceutical Quality Control Association, for example, all offer GMP certification programs for professionals of varying levels of experience.

The first official ASQ GMP-professional exam will be given in December but several pilot exams will be offered this spring and summer. The exam fee is $230 for ASQ members and $390 for nonmembers. The exam application is online here and a reference list of suggested study documents are online as well:  http://www.asq.org/certification/pharmaceutical-gmp/bok.html   and
http://www.asq.org/certification/pharmaceutical-gmp/references.html .