GMP and GLP Certifications

Written by lee haas
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GMP and GLP Certifications
Applicants must take a series of courses and pass tests for certification. (taking test image by Petro Feketa from Fotolia.com)

The GMP and GLP are two certifications available to professionals in the pharmaceutical, medical device, and biotechnology industries. The Center for Professional Innovation and Education, commonly known as CfPIE, offers both certifications. Applicants for certification must complete a series of courses and pass several exams to earn the GMP or GLP credential.

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GMP Certification

The Current Good Manufacturing Practices Certified Professional, or cGMP, is designed for individuals who are responsible for compliance within pharmaceutical, biologic and biopharmaceutical development and manufacturing industries. To receive certification, individuals must complete four training courses through CfPIE. Three courses must be from among the core courses, which include topics such as computer systems validation, good manufacturing practices, process validations and reporting procedures. For the final course, individuals may choose from among 13 elective courses on topics such as FDA regulations and inspections, technical writing, project management, basics of finance and quality assurance auditing. After completing each course, applicants must pass the course exam to earn certification credentials.

GLP Certification

The Current Good Laboratory Practices Certified Compliance Professional (cGLP) is geared to those responsible for compliance in a laboratory setting. Similar to GMP certification, applicants are required to complete four courses and pass the exam offered at the end of each course. The three required core courses are Effective Laboratory Safety Management, Good Laboratory Practices (GLP) for Pre-Clinical Testing and Writing Effective Standard Operating Procedures and Other Process Documents. For the fourth course, individuals may choose from among seven courses covering topics such as FDA regulations, stability testing, technical writing, project management and statistical analysis of laboratory data.

About CfPIE Certifications

Regulatory agencies of the life sciences industries sometimes require a GMP, GLP or other CfPIE certification. Professionals may also choose to pursue certification for skills enhancement or job growth potential. In addition to these certification programs, CfPIE offers training and professional development courses, as well as seven other certifications, in the areas of biotechnology, biopharmaceuticals, medical devices, pharmaceuticals and skin and cosmetics.

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