Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)

1. Overview of
ASQ Certified Pharmaceutical
GMP Professional (CPGP)
Seetharam Kandarpa, ASQ CQA & ASQ CPGP
Chair- Healthcare
ASQ Mumbai LMC

2. Contents
• About Author
• Overview of ASQ
– About ASQ
– ASQ Membership
– ASQ Certification
• Overview of ASQ CPGP
– Basics
– Requirements
– Body of Knowledge
– Application Process
– Examination
– Recertification

3. About Author
• Having 14+ years of versatile industrial experience in QA and Production functions at
API/ Formulation facilities (approved by various regulatory agencies USFDA, TGA,
MHRA, WHO etc.) of top pharma companies in India such as Aurobindo Pharma Ltd.,
Mylan Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Ipca Laboratories Ltd. and
Abbott Healthcare Pvt. Ltd.
• Having experience in handling Regulatory Inspections of USFDA, MHRA, WHO, TGA,
KFDA and PMDA.
• Having Training on Culture of Quality and Data Integrity Assurance by Dr. Ajaz S
Hussain.
• Having Training and certification on 'Cleaning Validation' by Destin A. Leblanc.
Seetharam Kandarpa, ASQ CQA & ASQ CPGP
Chief Manager Quality Assurance
Abbott Healthcare Pvt. Ltd.
http://seetharamkandarpa.webnode.in

4. OVERVIEW OF ASQ

5. ASQ – A Global Voice of Quality
ASQ is the world’s leading
community of people passionate
about quality – experienced individuals and
companies who strive for continual improvement
and help each other achieve it.
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6. About ASQ
• ASQ (American Society for Quality) (www.asq.org or asq.org.in)
– ASQ provides the global community with the expertise, tools, and solutions to help
organizations and individuals improve the products, services, and experiences we rely upon
for our safety, health, and daily lives. ASQ’s mission is to increase the use and impact of
quality in response to the diverse needs of the world.
– Founded in 1946, ASQ has been at the forefront of the quality movement. ASQ traces its
beginnings to the end of World War II, as quality experts sought ways to sustain quality
improvement. Today, ASQ continues to support innovations in many fields.
– ASQ provides the quality community with training, professional certifications, and knowledge
to a vast network of members of the global quality community.
– Headquartered in Milwaukee, Wisconsin, USA, ASQ champions people passionate about
quality in more than 150 countries. ASQ operates Regional Centers in North Asia, South Asia,
Latin America and the Middle East/Africa. ASQ’s global offices provide local access to the
quality community, career development, credentials, knowledge, and information services.
– Read ASQ’s online brochure.
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7. ASQ Membership
• Why Join ASQ?
– Whether you’re looking to connect with other professionals, advance your
knowledge and career, or grow your reputation as a thought leader, ASQ got the
membership that’s right for you.
• ASQ offers the following memberships:
– Full membership
– Associate membership
– Student membership
– Senior membership
– Fellow membership (members only)
– Honorary membership
– Enterprise Quality Roundtable organizational membership
– Corporate organizational membership
• Membership Benefit Matrix
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8. ASQ Certification
• ASQ certification is a formal recognition by
ASQ that an individual has demonstrated a
proficiency within, and comprehension of, a
specific body of knowledge. Nearly 300,000
certifications have been issued to dedicated
professionals worldwide.
• Recognized globally, ASQ certifications are
essential development tools that help quality
professionals show they’re on top—of
regulations, of expertise, and of industry
standards. People with ASQ credentials don’t
just improve their companies’ bottom lines; they
build careers.
• For more details:
– asq.org/cert
– 8 step guide
– ASQ Certification and Certification Preparation Tools
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9. ASQ Certification
• ASQ offers 18 certifications, many translated into four languages,
including basic quality tools, Six Sigma programs, quality engineering,
and management.
• Biomedical Auditor CBA
• Calibration Technician CCT
• HACCP (Food Safety) Auditor CHA
• Manager of Quality Organizational
Excellence CMQ/OE
• Master Black Belt CMBB
• Pharmaceutical GMP Professional
CPGP
• Quality Auditor CQA
• Quality Engineer CQE
• Quality Improvement Associate CQIA
• Quality Inspector CQI
• Quality Process Analyst CQPA
• Quality Technician CQT
• Reliability Engineer CRE
• Six Sigma Black Belt CSSBB
• Six Sigma Green Belt CSSGB
• Six Sigma Yellow Belt CSSYB
• Software Quality Engineer CSQE
• Supplier Quality Professional
CSQP
NOTE: Don’t Confuse Certification With a Training Certificate
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10. OVERVIEW OF
ASQ CPGP

11. Basics
• The Certified Pharmaceutical GMP Professional understands the
good manufacturing practices (GMP) as regulated and guided by
national and international agencies for the pharmaceutical industry.
This covers finished human and veterinary drugs and biologics,
ectoparasiticides, and dietary supplements (alternatively called
nutraceuticals) where regulated as drug products, as well as their
component raw materials (includes active pharmaceutical ingredients
(APIs) and excipients), and packaging, and labeling operations.
• Pharmaceutical GMP Professional Certification Brochure
• Certified Pharmaceutical GMP Professional Body of Knowledge
• Read some common questions about the CPGP
For More Details: asq.org/cert/pharmaceutical-gmp Back to Contents

12. Requirements
• Work Experience
– Work experience must be in a full time, paid role. Paid intern, co-op or any other
course work cannot be applied towards the work experience requirement.
– Candidates must have five years of on-the-job experience in one or more of the
areas of the Certified Pharmaceutical GMP Professional Body of Knowledge.
– A minimum of three years of this experience must be in a decision-making
position. "Decision-making" is defined as the authority to define, execute, or
control projects/processes and to be responsible for the outcome. This may or may
not include management or supervisory positions.
• Education
– There are no education waivers for this exam.
For More Details: asq.org/cert/pharmaceutical-gmp Continues…

13. Requirements
• Expectations
– Will have a fundamental understanding of regulatory agency governance including, global
regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.
– Will be able to develop and apply elements and requirements of a quality system, evaluate
various types of audits and self-inspections, and analyze documents and record management
systems.
– Will be able to distinguish between and verify suitability of factors relating to laboratory
systems, including relevant compendia for U.S., Europe and Japan, investigations of aberrant
laboratory results, and instrument control and record-keeping.
– Will be able to determine requirements and specifications for construction of facilities,
utilities and equipment, evaluate automated or computerized systems, and apply business
continuity plans and disaster recovery techniques
For More Details: asq.org/cert/pharmaceutical-gmp Continues…

14. Requirements
• Expectations
– Will be able to use sampling plans and apply procedures for shipping and receiving
materials, analyze in-house storage, identification, and rotation of materials, and meet
requirements for materials traceability and sourcing, including returned goods.
– Will have a thorough understanding of sterile and non-sterile manufacturing systems and
be able to analyze master and completed batch records, material control procedures, and
contamination controls.
– Will have a thorough understanding of product design factors and phase-appropriate
GMP requirements. Will be able to develop and evaluate filling and packaging operations and
controls, and analyze technology transfer activities.
For More Details: asq.org/cert/pharmaceutical-gmp Continues…

15. Body of Knowledge
• This BOK includes subtext explanations and corresponding cognitive levels for each
topic or subtopic.
• These details will be used by the Examination Development Committee as guidelines
for writing test questions and are designed to help candidates prepare for the exam by
identifying specific content that can be tested.
• The subtext is not intended to limit the subject matter or be all-inclusive of what might
be covered in an exam but is intended to clarify how topics relate to the role of the
Certified Pharmaceutical GMP Professional (CPGP).
• The descriptor in parentheses at the end of each subtext entry refers to the highest
cognitive level at which the topic will be tested. A more complete description of
cognitive levels is provided at the end of this document.
For More Details: asq.org/cert/pharmaceutical-gmp
Certified Pharmaceutical GMP Professional
Body of Knowledge
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16. Body of Knowledge
For More Details: asq.org/cert/pharmaceutical-gmp
I. Regulatory Agency Governance (15 Questions)
• A. Global regulatory framework B. Regulations and guidances
• C. Mutual recognition agreements D. Regulatory inspections
• E. Enforcement actions F. Regulatory agency reporting
• G. Site Master File (SMF), Validation Master Plan (VMP) and Drug Master File (DMF) and Site Reference File
(SRF)
II. Quality Systems (27 Questions)
• A. Quality management system (QMS) B. Quality unit (site) management
• C. Risk management D. Training and personnel qualification
• E. Change control and management F. Investigations and corrective and preventive action (CAPA)
• G. Audits and self-inspections H. Documents and records management
• I. Product complaints and adverse event reports J. Product trend requirements
• K. Supplier and contractor quality management
III. Laboratory Systems (21 Questions)
• A. Compendia (United States, Europe, and Japan) B. Laboratory investigations of atypical results
• C. Instrument management D. Specifications
• E. Laboratory record-keeping and data requirements F. Laboratory handling controls
• G. Stability programs H. Reserve samples and retains
IV. Infrastructure: Facilities, Utilities, Equipment (17 Questions)
• A. Facilities B. Utilities
• C. Equipment D. Qualification and validation
• E. Maintenance and metrology systems F. General cleaning, sanitization, and sterilization systems
• G. Automated or computerized systems H. Business continuity and disaster recovery planning
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17. Body of Knowledge
For More Details: asq.org/cert/pharmaceutical-gmp
V. Materials and Supply Chain Management (17 Questions)
• A. Receipt of materials B. Sampling processes
• C. Material storage, identification, and rotation D. Shipping and distribution
• E. Traceability and sourcing F. Salvaged/returned goods and destruction
VI. Sterile and Nonsterile Manufacturing Systems (22 Questions)
• A. Master batch and completed batch records B. Production operations
• C. In-process controls D. Dispensing and weighing controls
• E. Requirements for critical unit processes F. Contamination and cross-contamination
• G. Reprocessed and reworked materials
VII. Filling, Packaging, Labeling (18 Questions)
• A. Filling operations and controls B. Environmental monitoring
• C. In-process and finished goods inspections D. Product inspection
• E. Packaging operations and controls F. Labeling operations and controls
• G. Filling and packaging records
VIII. Product Development and Technology Transfer (13 Questions)
• A. Quality by design concepts B. Phase-appropriate GMP requirements
• C. Raw materials, packaging, and infrastructure for product development
• D. New product development studies and reports E. Scale-up and transfer activities
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18. Body of Knowledge
• Levels of Cognition Based on Bloom’s Taxonomy – Revised (2001)
– Remember
• Recall or recognize terms, definitions, facts, ideas, materials, patterns, sequences, methods, principles,
etc.
– Understand
• Read and understand descriptions, communications, reports, tables, diagrams, directions, regulations,
etc.
– Apply
• Know when and how to use ideas, procedures, methods, formulas, principles, theories, etc.
– Analyze
• Break down information into its constituent parts and recognize their relationship to one another and how
they are organized; identify sublevel factors or salient data from a complex scenario.
– Evaluate
• Make judgments about the value of proposed ideas, solutions, etc., by comparing the proposal to specific
criteria or standards.
– Create
• Put parts or elements together in such a way as to reveal a pattern or structure not clearly there before;
identify which data or information from a complex set is appropriate to examine further or from which
supported conclusions can be drawn.
For More Details: asq.org/cert/pharmaceutical-gmp
Mapping Questions vs Levels of
Cognition
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19. Application Process
• Fee Details:
– ASQ Members $348 (save $150) / ₹23,000* (Save ₹9,900)
– Non-members $498/ ₹32,900*
– Retakes $298/ ₹19,700*
• Become a Member
• Apply Now
• Download an Application (CBT Delivered Exams) (PDF,
148 KB)
*Price includes $70/ ₹4600 non-refundable fee.
For More Details: asq.org/cert/pharmaceutical-gmp Back to Contents

20. Examination
• Each certification candidate is required to pass an examination that consists
of multiple-choice questions that measure comprehension of the Body of
Knowledge.
• Computer Delivered - The CPGP examination is a one-part, 165- multiple
choice question, four-and-a-half-hour exam and is offered in English only.
150 multiple choice questions are scored and 15 are unscored.
• Paper and Pencil - The CPGP examination is a one-part, 150- multiple
choice question, four-hour exam and is offered in English only.
• All examinations are open book, with the exception of the constructed
response (essay) portion of the CMQ/OE exam. Each participant must bring
his or her own reference materials. Use of reference materials and
calculators is explained in the FAQs.
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21. Examination
• Computer-Based Testing Dates
– ASQ certification examinations are delivered by ASQ's testing partner, Prometric.
The examination scheduling instructions in your eligibility letter will direct you to a
section of Prometric's website, where you can select and schedule your
examination date and location.
• Prepare for Exam
– References
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22. Examination
– Books
• The Certified Pharmaceutical GMP Professional
Handbook, Second Edition
• The FDA and Worldwide Current Good
Manufacturing Practices and Quality System
Requirements Guidebook for Finished
Pharmaceuticals
• Handbook of Investigation and Effective CAPA
Systems, Second Edition
• Quality Risk Management in the FDA-Regulated
Industry
• Statistical Process Control for the FDA-
Regulated Industry
• Development of FDA-Regulated Medical
Products: A Translational Approach, Second
Edition
• Search for more ASQ books
For More Details: asq.org/cert/pharmaceutical-gmp
• Prepare for Exam
– Training
• Need training options? ASQ Sections
and ASQ Forums/Divisions offer more
training opportunities
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23. Examination
• Is Exam tough or easy?
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Exam is neither tough nor easy

24. Recertification
• Recertification
– To maintain the integrity of your Pharmaceutical GMP
Professional certification, ASQ requires that you recertify every
three years.
– Find out the steps you need to take for recertification.
– CREDENTIAL HOLDERS MUST:
• Obtain 18 recertification units (RUs) within a three-year recertification period.
Or
• Retake the certification exam at the end of the 3-year recertification period.
Fore more details: https://asq.org/cert/recertification
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25. Q&A
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26. Thank You
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