Why Can't ISPE Join Up With ASQ? Did You Know About ASQ's Certified Pharmaceutical GMP Professional Program?
A number of speakers at ISPE's conference referred to the Certified Pharmaceutical Industry Professional (CPIP) program that the organization has rolled out, providing certification that an industry professional has met a certain agreed-upon level of competence in GMPs and other critical subject areas.
A growing number of very sharp people in the industry have signed up for this and are now "certified." I was very surprised to learn, though, that ASQ also offers a GMP certification program for pharma professionals. Last week, I interviewed ASQ Senior member Robert Seltzer of Schering-Plough, who first had the idea for this certification test and program about five years ago. The first official tests will be given soon, and ASQ expects a large number of people to apply to take the exam. Mr. Seltzer says that this exam is geared to senior level practitioners, where ISPE's is more for entry-level people. However, I noticed that quite a few of the CPIPs are mid-level or seniorish level professionals.
Both programs are probably excellent, but isn't it confusing to have two different programs that claim to accomplish the same thing? I wondered why ISPE and ASQ couldn't work together on this, or at least promote each other's programs...in general, wouldn't it be interesting if ISPE collaborated with ASQ on more projects (and brought more examples from outside pharma, in areas such as continuous quality improvement, PAT, FMEA, etc.). After all, ASQ works across many different industries, each with a different lesson to impart? Just a thought....
In the meantime, here is some very basic information on ASQ's program. The podcast interview with Mr. Seltzer and a sample of mock exam questions will be coming your way on November 11 (if you subscribe to our PharmaManufacturing enews and multimedia alerts). If not, please contact me around that time for more information or check our web site in the middle of next month.
AMS
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ASQ Certified Pharmaceutical GMP Professional (CPGP)
Proposal for Adopting a New Certification for Pharmaceutical and Allied Industry Professionals to Demonstrate an Intermediate to Advanced Knowledge of Worldwide Pharmaceutical Good Manufacturing Practices (GMP) Laws, Regulations, Guidelines, Standards, and Principles, etc.
I. EXECUTIVE SUMMARY:
The proposed ASQ Certified Pharmaceutical GMP Professional (CPGP) exam is the revised name and acronym from the earlier proposed name, Certified Pharmaceutical GMP Compliance Professional (CPGMPCP). This was suggested by both the ASQ Certification Board and by the Board of the Food, Drug and Cosmetic Division of ASQ. In addition to opting for a shorter name and acronym, it was acknowledged that not all professionals who would sit for the exam are employed in strictly “compliance” but function in many other job titles/categories that make significant use of pharmaceutical Good Manufacturing Practices.
This proposed certification differs from other ASQ sector-specific certifications—CBA (Biomedical) and CHA—in that it would apply to/appeal to professions in addition to auditors:
CBA = Medical Device Industry + Device Quality Stds + Auditors
CHA = Food Industry + HACCP Regs/Principles + Auditors
VERSUS
CPGP = Pharmaceutical Industry + Pharma GMP Regs/Principles + Professionals
As decided by the committee chartered by the FDC Division Board, namely the PharmCert Committee of FDC, the CPGP exam should be made available to pharmaceutical and allied industry professionals that interpret and implement the GMP laws, regulations, guidelines, standards, and principles enacted and/or published domestically and internationally. The potential CPGP examinees...would need five (5) or more relevant years of experience in the pharmaceutical or allied industries to sit for the exam, as this is not an entry-level GMP exam. Such an exam would cover nine Body of Knowledge categories with weights determined via a Job Analysis drafting and survey process.
The key benefits of obtaining the CPGP Certification by individuals (as well as the benefits accruing to the companies for whom they work) are as follows:
• Enables company individuals and management to raise the GMP compliance “bar” to a higher level.
• Supports internal company programs of Continuous Quality Improvement (CQI).
• It is sector-specific applied knowledge.
• It’s a source of professional and personal pride.
• Enhances a professional’s credibility and standing with outside business partners.
.
Body of Knowledge Category/% of Cert. Exam
I. Regulatory Agency Governance 14.1
II. Quality Systems 21.9
III. Laboratory Systems 11.6
IV. Infrastructure (Facilities, Equipment, & Utilities) 9.1
V. Materials Management/Supply Chain 8.8
VI. Sterile and Nonsterile Mf’g Systems 10.1
VII. Filling, Packaging, and Labeling 9.9
VIII. Product Development 7.6
IX. Technology Transfer 6.9
Total =
100.0
