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Exam Information
Official specifications published by ASQ
Exam Format
258 min
165
550/750
Professional
Registration
Prometric or online proctoring
English
Validity
3 years
Accumulate 30 Continuing Education Units (CEUs) during the 3-year validity period; Submit a renewal application and pay the renewal fee
CPGP Exam Topics and Domains
CPGP is organized into 8 weighted domains. Expect to work with EMA, FDA, Health Canada, FDA 21 CFR Part 11, and more.
1
Regulatory Agency Governance
11.33%
Global regulatory framework
- Acts
- Statutes
- Directives
- Pharmaceutical legislation
- FDA FD&C Act
- EU Directive 2001/83/EC
- Identifying which regulatory frameworks apply to specific pharmaceutical scenarios
- Distinguishing between acts, statutes, and directives across jurisdictions
- FDA
- EMA
- Health Canada
- TGA
- PMDA
Identify the acts, statutes, and directives that apply to pharmaceuticals.
Regulations and guidances
- PIC/S
- ICH guidelines
- WHO GMP
- EMA guidelines
- FDA regulations
- Health Canada guidelines
- USDA 9CFR
- ISO standards
- 21 CFR Parts 210/211
- EU GMP Eudralex Volume 4
- Interpreting GMP regulations from different agencies
- Distinguishing between guidelines, guidances, and enforceable regulations
- Applying ICH quality guidelines (Q7, Q9, Q10, Q12)
- PIC/S
- ICH
- WHO
- EMA
- FDA
- Health Canada
- USDA
Interpret frequently used regulations and guidelines/guidances/drafts including those published or administered by PIC/S, ICH, WHO, EMA, FDA, Health Canada, USDA 9CFR, and other national regulatory agencies and international standards (e.g. ISOs).
Mutual recognition agreements
- Mutual Recognition Agreements (MRAs)
- Product registration
- Import/export requirements
- Inspection finding sharing
- PIC/S membership
- Understanding how MRAs affect product registration
- Import/export regulatory requirements for raw materials and finished products
- FDA
- EMA
- Health Canada
- TGA
Interpret requirements that govern product registration, import or export of raw material or finished product, and the sharing of inspection findings.
Regulatory inspections
- Pre-approval inspections (PAI)
- System-based inspections
- For-cause inspections
- License renewal inspections
- Remote evaluations
- Record requests
- Digital reporting
- Inspection readiness
- Differentiating inspection types and their triggers
- Preparing for and hosting regulatory inspections
- Understanding inspection frequency requirements
- FDA
- EMA
- Health Canada
- WHO
- Define and describe various types of inspections including pre-approval, system-based, for-cause, and license renewal, and describe the frequency for each.
- Describe how to prepare for and host in-person and remote evaluations and how to accommodate record requests and digital reporting.
Enforcement actions
- Warning letters
- Consent decrees
- License withdrawals
- Product seizure
- Import alerts
- Form 483 observations
- Injunctions
- Criminal prosecution
- Identifying types of enforcement actions and their severity
- Understanding consequences of GMP non-compliance
- Distinguishing between enforcement actions across regulatory agencies
- FDA
- EMA
- Health Canada
- WHO
Define and describe various global enforcement actions and consequences (e.g., warning letters, consent decree, license withdrawals, product seizure, and import alerts).
Regulatory agency reporting
Post-marketing changesRegulatory reporting requirementsProduct surveillance
- Describe how post-marketing changes are assessed for impact to determine reporting method.
- Describe global reporting requirements including supplements, field alerts, BPDRs, adverse events, recalls, annual reports, and variations.
- Describe monitoring requirements for REMS and pharmacovigilance.
Site Master File (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)
- Site Master File (SMF)
- Validation Master Plan (VMP)
- Drug Master File (DMF)
- Site Reference File (SRF)
- PIC/S SMF format
- FDA DMF types
- Purpose and content of each master file type
- Distinguishing between SMF, VMP, DMF, and SRF
- PIC/S
- FDA
- EMA
Describe the purpose and content of Site Master Files (SMFs), Validation Master Plans (VMPs), Drug Master Files (DMFs), and Site Reference Files (SRFs).
2
Quality Systems
17.33%
Quality management system (QMS)
- QMS structure
- ICH Q7
- ICH Q10
- EU GMP
- Management review
- Pharmaceutical Quality System (PQS)
- CAPA
- Knowledge management
- Continual improvement
- Key elements of a pharmaceutical QMS
- Management review requirements
- Differences between ICH Q7 (APIs) and ICH Q10 (PQS)
- ICH Q7
- ICH Q10
- EU GMP Eudralex Volume 4
- Describe key elements of the structure of a Quality Management System (QMS).
- Outline the requirements for the development, operation, and management review for suitability and effectiveness as defined in ICH Q7, ICH Q10, EU GMP, and other guidances.
Quality unit (site) management
- Qualified Person (QP)
- Management Representative
- Batch release
- Disposition
- Quality unit independence
- Investigational products
- Commercial products
- Roles and responsibilities of the quality unit
- Batch release requirements
- Independence of quality unit from operations
- EU GMP
- FDA 21 CFR 211
Describe quality management elements for individual sites or units including responsibilities for the quality unit management such as Qualified Person, Management Representative, batch release (disposition) requirements for investigational and commercial products, and the need for quality units to be independent from operations.
Risk management and assessment
Risk managementRisk assessment
- Use various methods to apply risk management principles as described in ICH Q9, ICH Q12, and other guidance and regulatory documents.
- Use the Quality Management Maturity (QMM) assessment program to assess QMS effectiveness.
Training and personnel qualification
Needs analysisStaff development requirementsTraining effectiveness and role of supervisor
- Identify requirements for determining the type of training, qualification, and experience needed.
- Determine proof of proficiency based on regulations.
- Apply various methods for testing and evaluating training effectiveness.
Change control and management
Pre-change analysisChange implementationPost-change analysis
- Assess the impact of proposed changes on products, processes, facilities, utilities, and systems.
- Implement and document the change following a change implementation plan.
- Analyze data to determine results of a change and evaluate new risk factors.
Investigations and corrective and preventive action (CAPA)
Trigger eventsResponse actionsCAPA feedback and trending
- Identify events that require investigation, root cause analysis, and impact assessment.
- Define immediate action, corrective action, preventive action, and methods of implementing them.
- Describe how CAPA trending is used to modify appropriate quality system elements.
Audits and self-inspections
Audits processes and resultsAudit follow-up
- Develop audit schedules, differentiate audit types, document evidence, and analyze results.
- Use various methods to evaluate and verify effectiveness of corrective actions.
Documents and records management
GMP document systemRecordsRecord retention
- Describe the GMP document system to determine compliance.
- Review records to confirm compliance to ALCOA and PIC/S data integrity guidelines.
- Identify regulatory requirements for record retention.
Product complaints and adverse event reports
Product complaintsAdverse eventsEvent response
- Describe and distinguish between product complaints and adverse events.
- Describe regulatory requirements for reporting adverse events.
- Evaluate the level of action needed in response to adverse events.
Product trend requirements
- Annual Product Review (APR)
- Product Quality Review (PQR)
- Data trending
- Statistical analysis
- Periodic product assessment
- Distinguishing between APR and PQR requirements
- Understanding data trending in product reviews
- FDA 21 CFR 211.180(e)
- EU GMP Chapter 1
Describe and distinguish between components of periodic product assessment, such as the U.S. annual product review (APR) and the European product quality review (PQR), with regard to data trends and other required elements.
Supplier and contractor quality management
Supplier quality systemsSupplier controlsSupplier evaluationQuality agreementsOutsource processes
- Identify and interpret standards related to supplier/vendor/contractor QMS monitoring.
- Assess adequacy of controls over supplier selection and procurement.
- Assess quality systems of suppliers using various methodologies.
- Explain purpose and describe main elements of quality agreements.
- Use methods for managing outsourcing activities.
3
Laboratory Systems
13.33%
Compendia (United States, Europe, and Japan)
Required vs. informational compendiaMarketing requirements vs. compendiaCompendial methods reviewCompendial or non-compendial requirements reviewBiological, microbiological, chemical, and physical test methods
- Describe and distinguish between required and informational compendial chapters.
- Distinguish among USP, EP, and JP for marketing authorization.
- Review compendial methods for suitability.
- Review test methods against required compendial chapters.
- Identify and interpret results from compendia tests.
Laboratory investigations of atypical results
Test dataAtypical results
- Describe and develop procedures for investigating each type of test data.
- Identify, analyze, and interpret OOS/OOT data and determine investigation outcomes.
Instrument management
Instrument controlsInstrument calibration
- Apply operating procedures for instrument identification, classification, qualification, calibration, and preventive maintenance.
- Determine instruments are calibrated within specified range and are accurate and precise.
Specifications
Types of specificationsTest data and specificationsSpecifications revision
- Determine whether approved specifications exist for all material types.
- Compare test data with specifications to determine compliance.
- Review and update specifications when methods are revised or compendia change.
Laboratory record-keeping and data requirements
Record-keeping requirementsRecord reviewCertificates of analysis (COAs)
- Identify and review record-keeping requirements for data integrity.
- Review laboratory records including audit trails to detect errors and fraud.
- Review COAs for completeness and proper retention.
Laboratory handling controls
Sample handlingReagents, solutions, and standards identificationStorage requirements
- Determine proper sample identification and handling.
- Determine proper identification and labeling of reagents, solutions, and standards.
- Describe and use procedures for appropriate storage conditions.
Stability programs
Release tests vs. stability-indicating testsStability test dataStability-point failure
- Define and distinguish between release and stability-indicating tests.
- Review stability data against specifications and identify trends.
- Identify stability-point failures and evaluate regulatory implications.
Reserve samples and retains
- Retain samples
- Reserve samples
- Regulatory requirements
- Storage conditions
- Sample quantity
- Retention period
Understanding regulatory requirements for retains and reserve samples
- FDA 21 CFR 211.170
- EU GMP Annex 19
Describe the various regulatory requirements for retains and reserve samples.
4
Infrastructure: Facilities, Utilities, and Equipment
11.33%
Facilities
BuildingsManufacture and storage environmentFacilities change control
- Determine building requirements for proper operation and cross-contamination prevention.
- Identify requirements for appropriate lighting, ventilation, and drainage.
- Verify change control practices maintain qualified state of facilities.
Utilities
Water supply systemsCompressed air and gas systemsUtility design for productionUtilities design specificationsUtilities change control
- Identify water system design requirements for different water types.
- Apply regulatory requirements for compressed air and gas systems.
- Select utility designs for specific production steps.
- Review operations to ensure design specification compliance.
- Verify change control maintains qualified state of utilities.
Equipment
Equipment planningEquipment layoutEquipment cleaning and maintenanceEquipment cleaning validation or verificationEquipment change control
- Review equipment location, design, construction, installation, and maintenance.
- Determine equipment layout to minimize errors and contamination.
- Review cleaning and maintenance procedures.
- Evaluate cleaning validation methodology.
- Verify change control maintains qualified state.
Qualification and validation
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process validation
- Understanding the qualification lifecycle from FAT/SAT through DQ/IQ/OQ/PQ
- Relationship between equipment qualification and process validation
- EU GMP Annex 15
- FDA Process Validation Guidance
Verify that qualifications and validations of facilities, equipment, and utilities are conducted in accordance with requirements including FAT/SAT, DQ/IQ/OQ/PQ prior to process validation.
Maintenance and metrology systems
Maintenance proceduresMetrology change control
- Verify maintenance procedures for HVAC, filters, and utilities.
- Verify calibration and metrology program exists for manufacturing instruments.
General cleaning, sanitization, and sterilization systems
Cleaning proceduresSanitization proceduresPest controlSterilization processes
- Review cleaning procedures in accordance with cleaning validation.
- Review sanitization procedures and validation studies.
- Verify pest control program.
- Verify sterilization processes are established and validated.
Automated or computerized systems
Validation proceduresOpen and closed computerized systemsConfiguration controlSecurity requirements
- Review procedures for computerized system implementation and validation.
- Distinguish between open and closed computerized systems.
- Verify version control and configuration management.
- Evaluate computerized systems for regulatory security requirements.
Business continuity and disaster recovery planning
Supply chain impactContingency plan
- Review disaster recovery and business continuity plans.
- Verify testing and effectiveness of contingency plans.
5
Materials and Supply Chain Management
11.33%
Receipt of materials
Incoming materialsInventory controls
- Describe and use processes for receiving, labeling, and storing incoming materials.
- Describe and use procedures for inventory documentation and quality holds.
Sampling processes
Sampling plansSampling environmentCleaning
- Review sampling plans for representative sampling.
- Differentiate sampling environment requirements by material type.
- Ensure sampling environment and utensils are appropriately cleaned.
Material storage, identification, and rotation
Storage suitabilityLabelling of stored materialsStock rotationRetest dates vs. expiration datesMix-up risk
- Ensure storage environment is suitable and monitored.
- Confirm stored materials have proper identification labels.
- Define and use FIFO and FEFO stock rotation.
- Describe difference between retest and expiration dates.
- Identify potential mix-up sources and mitigation methods.
Shipping and distribution
Temperature-sensitive requirementsSpecial requirementsReport requirementsSupply chain security
- Identify requirements for temperature-sensitive products.
- Determine and apply product-specific shipping requirements.
- Analyze shipping reports per GDP.
- Apply various supply chain security means.
Traceability and sourcing
Traceability requirementsBiological agent requirementsPedigree and sourcing requirements
- Define and differentiate traceability requirements.
- Apply requirements for biological agents.
- Maintain pedigree and sourcing details through the supply chain.
Salvaged/returned goods and destruction
DispositionDestruction facilities and processes
- Review salvaged and returned goods for disposition.
- Determine destruction requirements for materials.
6
Sterile and Nonsterile Manufacturing Systems
14.67%
Master batch and completed batch records
Required elementsRecord processing requirements
- Review batch records for required elements.
- Confirm batch records meet execution, review, and disposition requirements.
Production operations
Application factorsProcess operationsUtility requirementsSanitization and protection
- Differentiate manufacturing requirements by product type.
- Understand continuous vs batch manufacturing.
- Identify facility and utility requirements for different production environments.
- Identify production operations requiring gowning and sanitization.
In-process controls
In-process testingCritical process parameters (CPPs)Process capabilitySpecification limits
- Identify appropriate in-process tests for each manufacturing step.
- Monitor critical process parameters.
- Conduct process capability studies and calculate Cp and Cpk.
- Assess specification limits against requirements.
Dispensing and weighing controls
Staging areasDispensing materials
- Review dispensing and staging areas for compliance.
- Identify requirements for weighing equipment and handling utensils.
Requirements for critical unit processes
Process parametersValidation studiesUnit operationsOperating proceduresRe-evaluation and revalidationEnvironmental monitoring requirementsEnvironmental monitoring tools
- Use critical process parameters for unit processes.
- Evaluate validation studies for critical unit processes.
- Assess unit processes for deviations.
- Confirm validated parameters in operating procedures.
- Determine revalidation criteria and frequency.
- Differentiate environmental monitoring by area classification.
- Describe and use environmental monitoring tools.
Contamination and cross-contamination
SourcesRisk mitigation
- Identify contamination sources and implement controls.
- Apply various techniques for contamination risk mitigation.
Reprocessed and reworked materials
Disposition processStorage
- Distinguish reprocessing from reworking.
- Describe requirements for segregation and secure storage.
7
Filling, Packaging, and Labeling
12%
Filling operations and controls
Materials controlFilling equipment controlContamination controlsStaged materialsStatus labeling
- Develop procedures for material identity, strength, and purity.
- Analyze filling equipment controls.
- Identify contamination controls during filling.
- Review staged materials for approval.
- Apply proper status labeling.
Environmental monitoring
- Active air sampling
- Settling plates
- Swab sampling
- Nonviable particle counting
- Contact plates
- Surface monitoring
- Personnel monitoring
Using environmental monitoring techniques during production operations
Use various monitoring techniques to determine appropriate environmental conditions during production.
In-process and finished goods inspections
InspectionsVision and detection systemsDefect characterizationsEquipment failure detection
- Develop in-process and finished goods inspection criteria.
- Ensure vision and detection systems are qualified.
- Ensure defect characterizations are identified.
- Confirm equipment failures can be detected.
Product inspection
Staff evaluationInspector requirementsAutomated inspection processes
- Ensure inspection staff are trained and meet reproducibility requirements.
- Establish inspector requirements.
- Ensure automated inspection processes are validated.
Packaging operations and controls
Content protectionQualification and maintenance of equipmentLine clearance operationsQuality check criteriaCut-label proceduresHand-applied label proceduresPackaging controlsContamination controlsTamper-evident packaging
- Develop procedures to protect package content.
- Ensure packaging equipment is qualified and maintained.
- Determine line clearance is performed and documented.
- Identify and apply quality check criteria.
- Apply procedures for cut labels and splices.
- Ensure hand-applied labels are 100% inspected.
- Distinguish controls for different packaging processes.
- Identify contamination controls at all packaging stages.
- Ensure tamper-evident and child-proof packaging requirements.
Labeling operations and controls
Label printing in packagingQuality of print usedLabel changesLabel reconciliationUnused labelsLabel productionAccess control
- Confirm printing during packaging is correct.
- Ensure print quality on packaging materials.
- Determine if regulatory notification is required for label changes.
- Confirm label reconciliation and discrepancy investigation.
- Confirm procedures for unused labels.
- Define label production terms.
- Ensure controls for labeling creation, storage, and issuance.
Filling and packaging records
TermsSetup instructions
- Define terms related to filling and packaging records.
- Ensure packaging line setup instructions are appropriate.
8
Product Development and Technology Transfer
8.67%
Quality by design concepts
Critical quality attributes (CQAs) and critical process parameters (CPPs)Design spaceProcess analytical technology (PAT) tools
- Identify CQAs for products and CPPs for processes.
- Define design space as used throughout the product lifecycle.
- Identify PAT tools and describe their use.
Phase-appropriate Good Manufacturing Practices (GMP) requirements
Product life cycle developmentDevelopment phasesCombination productsClinical trials material
- Apply phase-appropriate GMPs throughout the product lifecycle.
- Identify requirements for each development phase.
- Identify GMP requirements for combination products.
- Describe requirements for clinical trial material production.
Raw materials, packaging, and infrastructure for product development
- Development studies
- Raw material selection
- Critical quality attributes
- Material characterization
Selecting development studies and evaluating results for CQA determination
Select appropriate development studies for raw material selection and evaluate results to determine critical quality attributes.
New product development studies and reports
- Stability reports
- Material compatibility studies
- Method development
- Development reports
- Regulatory submissions
Analyzing development studies and reports for product submissions
Analyze studies and reports including stability reports, material compatibility, method development, and development reports to support product development and submissions.
Scale-up and transfer activities
Development and validation principlesTechnology transfer typesSuccessful technology transfer
- Distinguish between development and validation studies.
- Define technology transfer types and analyze inter-site comparisons.
- Define studies needed for successful technology transfer.
How do I earn this certification?
Passing CPGP earns the Certified Pharmaceutical GMP Professional (CPGP) certification. It sits in the Pharmaceutical Quality / GMP Compliance track.
Next Level Options
- CMQ/OE - ASQ Certified Manager of Quality / Organizational ExcellenceAdvances career to quality management and organizational leadership in pharmaceutical companies
- CMBB - ASQ Certified Master Black BeltAdvanced process improvement leadership applicable to pharmaceutical manufacturing excellence
Practice with Precision
The PlanetCert Simulator mirrors the real exam environment with authentic questions and timed pressure.
How to study for this exam?
The most effective way to prepare for CPGP is by using the PlanetCert Simulator to practice questions and review detailed explanations.
What's changed on this exam?
Current Status
- ACTIVE
- Last content update: 2023 Body of Knowledge revision
Updates
- EU GMP Annex 1 (Revised) 2023 Revision Directly impacts Domain VI sterile manufacturing questions and Domain IV facilities/equipment questions
- ICH Q9(R1) Quality Risk Management R1 Revision Updated risk management principles tested in Domain II
- ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Step 4 New guideline referenced in Domain II risk management content
- ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Step 4 Supports new process operations subtopic in Domain VI
Who should take this exam?
5 years of on-the-job experience in one or more areas of the CPGP Body of Knowledge
3 of those years must be in a decision-making position
- Experience in pharmaceutical GMP environment
- Familiarity with FDA, EU, and WHO GMP regulations
- Knowledge of quality systems and CAPA processes