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The Newest ASQ Certification The Certified Pharmaceutical GMP Professional (CPGP). VISION OF CPGP The ASQ Certified Pharmaceutical GMP Professional (CPGP) is a person who:

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The Newest ASQ Certification The Certified Pharmaceutical GMP Professional (CPGP)

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    1. The Newest ASQ Certification The Certified Pharmaceutical GMP Professional (CPGP)

    2. VISION OF CPGP • The ASQ Certified Pharmaceutical GMP Professional (CPGP) is a person who: • Understands and can implement the principles underlying the worldwide laws, regulations, directives, stds, guidances, compendia, etc. for pharma industry. • Must be able to distinguish GMP-compliant from noncompliant methods, activities, results, and reports, and be able to prevent or correct noncompliance.

    3. BoK Categories on PGP Exam

    4. Why a CPGP ? • FDA & other pharma inspectorates have intensive cert programs • EU has the Qualified Person (QP) batch releaser  • ASQ CQA is about Multi-Industry + Quality Stds + Auditors versus • ASQ CPGP is about Pharma + GMP Regulations + Professionals

    5. Companies that would Benefit from CPGP • Large, Medium, & Start-up Innovator Pharma • Generic Drug Manufacturers • API and other Raw Material Manufacturers • Contract Manufacturers & Repackers • Labeling/Packaging Component Suppliers • Pharma Durable and Disposable Equipment Suppliers • Critical Pharma Lab Reagent Suppliers • Pharma External Service Providers, e.g., contract metrology, eng’g, validation, QC test labs, consultants

    6. Job Titles/Categories that would Benefit from CPGP Individuals and management within the following depts: • Change Control/ Document Control • Engineering / Validation • GMP-Relevant R&D • Operations/ Commercial & Clinical Manufacturing • Quality Control (labs) • Quality Assurance/ Compliance/ Auditing • Supply Chain/ Logistics • Technology Transfer/ Technical Services

    7. FAQ #1 How does studying for & taking this ASQ cert exam possibly add to one’s knowledge or marketability? Keeping up with the ever-changing BoK enables a pharma GMP professional to keep up with the GMP compliance laws, regulations, standards, guidances, compendia, etc. Also, ASQ certifications are included in many pharma job descriptions.

    8. FAQ #2 Why should companies in or allied w/ the pharma industry get “on board” & encourage employees to certify to CPGP? • Preparing for & passing the CPGP exam greatly enables a company’s employees and mgm’t to raise the GMP compliance “bar” to a new level. • Supports internal program of Continuous Quality Improvement (CQI). • It is sector-specific applied knowledge.

    9. FAQ #3 Even if a person has been a pharmaceutical GMP professional for 5 – 30 yr, now wouldn’t he/she be in jeopardy of a “black mark” if he/she does not pass the exam? Wouldn’t my employer find out? On the contrary, now a veteran pharma GMP prof’l can take and pass a true test of his/her many areas of knowledge and interpretation in CGMPs. A candidate can take these tests an unlimited number of times w/o an employer knowing or learning results if the candidate pays his/her own application fee. The candidate could then get his/her employer to provide reimbursement after receiving the certification certificate (without disclosing how many tries it took).

    10. FAQ #4 If a person takes this exam and passes, how does he/she renew that certification and ensure the “C” in CGMP? Recertification in ASQ simply entails accumulating at least 18 recert units (RU’s) via course or seminar attendance, teaching, article/book- writing, participating on relevant committee(s), and remaining in the profession.

    11. FAQ #5 How would a person know if he/she is capable of taking and passing this exam? ASQ’s exam application contains sample questions.

    12. FAQ #6 Are there as many different GMP regulations as there are countries in the world? No. There are truly just five GMP regulations of real significance and sufficiently different to be worth studying: 1) US FDA’s; 2) EU GMPs = PIC/S = TGA; 3) WHO (World Health Organization) GMPs; 4) Japanese GMPs; and 5) Canadian GMPs

    13. FAQ #7What are the advantages of ASQ’s over ISPE’s or other marketed GMP certifications? 1. ASQ has no conflict of interest in administering certification exams: it does not mandate membership or the taking of ASQ-offered courses. One could apply, pay, and take the exam with “no strings attached.” This is quite the contrary in almost all the other GMP certifications. 2. ASQ, by virtue of its numerous, geographically dispersed local chapters, is able to offer reasonably-priced and highly accessible exam review courses and highly accessible exam sites. 3. ASQ has been creating and updating more than 13 certifications, all starting in 1984.

    14. FAQ #8Why would a Change Management, a Document Control, a Logistics, a Supply Chain, a Manufacturing, a Quality Control, a Technical Service, a Validation, or an R&D department member take this exam? This cert demonstrates understanding and implementation by oneself of the principles underlying the laws, regulations, directives, standards, guidances, compendia for manufacturing, testing, and holding finished pharmaceuticals, intermediates, and raw materials (including APIs and excipients).

    15. FAQ #9 Would this certification be likened to the EU Qualified Person? 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 turn a person into someone legally responsible for batch release decisions, which is the realm of the QP.

    16. FAQ #10What experience must one have to be allowed by ASQ to take this exam? What are an examinee’s qualifications? CPGP can be taken by persons with five (5) or more years of relevant pharmaceutical or allied industry experience using the pharmaceutical GMPs.

    17. FAQ #11 Should I assume that exam questions will not come from sources other than those given in the “reference list?” That is absolutely correct. If new exam questions derive from new sources, the latter will be added to the ASQ Certification website’s CPGP study “reference list.”

    18. FAQ #12 Would ASQ or the CPGP Exam Champion be able to provide an exam applicant with reference material to study for and take the exam? Part of the challenge of this test is the proof by the examinee that he/she can assemble the right references for the exam and can actually access them in real-life application.  The great majority of the references are free off the internet.  The only documents costing money are a) ISO standards (e.g., for cleanrooms, calibration laboratory, calibration of nonviable particulate air samplers, etc.), PDA Technical Reports (unless a person has been a member of PDA—they receive free the technical reports when published), and the pharmacopeias (e.g., USP, JP, EP). 

    19. FAQ #13 What recommendations do the Exam Champions have for the people studying for and taking the CPGP Exam? Obtain and study from the reference documents. The following 10 references are the most important: 1) 21CFR 211 2) EC GMPs Annex 1 3) ICH Q10--Quality Systems 4) FDA 2004 Guidance "Changes to an NDA/ANDA" 5) ICH Q7 6) USP General Notices 7) USP <1058> 8) World Health Organization GMPs 9) FDA Guide on Inspection of Water Systems 10) FDA Guidance on Aseptic Processing

    20. Sample of Exam Questions: 1. Which of the following dosage forms is a candidate for weight variation to be used in determining uniformity of dosage units? (A) Transdermal infusion patch w/ greater than 30% by weight active ingredient (B) An uncoated tablet with a greater than 50% by weight of active ingredient (C ) A suppository (D) An injectable suspension

    21. Sample of Exam Questions: The following two questions require selecting from the same four (4) choices: (A) Potable Water (B) Whichever water is compatible w/ the assays or disinfectant efficacy (C ) Compendial Purified Water (D) Compendial Water for Injection 1. According to EMEA or FDA, which minimum grade of water must be used to dilute disinfectants for Grade C cleanroom floors? 2. According to EMEA, which is the minimum grade of water that must be used for nonsterile nasal or ear preparations?

    22. In Closing: If you, in your job, career / future, need to understand, use, or oversee people, projects, or operations that come under pharma GMPs, why not enhance your professional credibility by studying for and obtaining this Pharmaceutical GMP Professional credential?

    23. Questions Please !