ICH Q10 Audit Checklist
Objective Evidence
- PQS scope statement covering drug substances and drug products
- Lifecycle stage identification for each product
- Evidence of PQS adaptation by lifecycle stage
- Product portfolio with lifecycle stage mapping
- Scope exclusions documented with justification
- Periodic scope review records
- Board-level or executive endorsement of PQS scope boundaries
Common Nonconformities
- PQS scope does not mention drug substances separately
- Same PQS applied identically across all lifecycle stages
- No documented scope statement
- Biotechnology/biological products excluded without justification
- Scope not reviewed when new products or stages are added
- Discontinued products still consuming PQS resources without reassessment
Auditor Tips
The PQS scope must explicitly cover both drug substances and drug products, and must be adapted to the lifecycle stage. A development-stage PQS will look different from a commercial manufacturing PQS. The scope statement should be documented and periodically reviewed.
Objective Evidence
- PQS policy statement referencing all three objectives
- Quality objectives aligned with product realisation
- State of control metrics and dashboards
- Continual improvement program documentation
- Management review minutes referencing objectives
- Annual PQS performance reports
- Quality planning documents
- Process performance trending data
Common Nonconformities
- PQS policy does not reference ICH Q10 objectives
- No measurable quality objectives defined
- State of control not defined or monitored
- No evidence of continual improvement activities
- Objectives only on paper, no active tracking
- Objectives not cascaded to site or departmental level
Auditor Tips
Organizations must demonstrate their PQS achieves all three ICH Q10 objectives. This is the overarching framework: products must be realized consistently, processes must be in a validated state of control, and mechanisms for continual improvement must be active and measurable.
Objective Evidence
- Knowledge management policy or framework
- Quality risk management policy referencing ICH Q9
- Integration of KM and QRM into PQS processes
- Examples of science-based and risk-based decisions
- Technology transfer knowledge packages
- Lessons learned databases
- Cross-functional process team charters referencing KM and QRM deliverables
Common Nonconformities
- Knowledge management not formalized
- Risk management done only for regulatory submissions
- No integration between KM/QRM and daily operations
- Enabler effectiveness never assessed during management review
- KM and QRM treated as separate projects rather than embedded PQS capabilities
- No documented criteria for when to invoke formal risk assessment versus informal review
Auditor Tips
Knowledge management and quality risk management are the two foundational enablers of the PQS. They are not standalone activities but must be integrated into all PQS processes (CAPA, change management, process monitoring, management review).
Objective Evidence
- PQS design rationale document
- Complexity assessment for PQS scope
- Risk-based justification for PQS structure
- Periodic PQS design review records
- Scalability considerations documented
- Comparison of PQS complexity to operational complexity
- Benchmarking against peer organizations with similar product portfolios
Common Nonconformities
- Overly complex PQS for a simple operation
- Overly simplistic PQS for complex multi-site operations
- PQS design never reassessed since initial implementation
- No risk management integrated into PQS design
- One-size-fits-all PQS across diverse product lines
- PQS structure unchanged despite acquisition of new manufacturing sites
Auditor Tips
The PQS must be right-sized. A small single-product company does not need the same complexity as a global multi-site corporation. The system design should be justified and periodically reassessed as the organization evolves.
Objective Evidence
- Quality manual or PQS description document
- Quality policy statement within the manual
- PQS scope statement
- Process maps showing PQS process interactions
- Organizational charts with quality responsibilities
- Document hierarchy description
- Cross-reference to detailed SOPs and procedures
- Site master file (where applicable)
Common Nonconformities
- No quality manual or equivalent document
- Quality manual outdated or does not reflect current operations
- PQS scope not clearly defined
- Process interactions not described
- Management responsibilities not defined
- Quality manual not distributed to or accessible by relevant site personnel
Auditor Tips
The quality manual (or equivalent) must describe the entire PQS scope, structure, and processes. It serves as the top-level document that provides an overview of how the quality system operates and who is responsible for what.
Objective Evidence
- PQS scope explicitly listing drug substance operations
- Drug substance manufacturing sites included in quality system
- API supplier quality agreements referencing PQS requirements
- ICH Q11 compliance assessment for drug substance development
- Drug substance process validation within PQS framework
- Contract drug substance manufacturer oversight records
- Fermentation or cell culture process lifecycle documentation
Common Nonconformities
- Drug substance operations excluded from PQS
- API manufacturing managed outside quality system
- No ICH Q11 linkage in development activities
- Contract API manufacturers not covered by quality agreements
- No traceability between drug substance batches and PQS records
- Intermediate hold-time studies absent from validation scope
Auditor Tips
Drug substance (API) manufacturing must be within PQS scope. This includes chemical synthesis, fermentation, cell culture, and extraction processes. ICH Q11 linkage ensures development and manufacturing of APIs are covered.
Objective Evidence
- Product quality review (PQR) / Annual Product Review (APR)
- Batch release records showing consistent quality
- Stability data demonstrating shelf-life compliance
- Specification compliance trending
- Customer complaint trends showing product quality
- Regulatory filing commitments mapped to controls
- Process capability indices (Cpk, Ppk)
- Right-first-time metrics
Common Nonconformities
- High batch failure rates
- Recurring OOS/OOT results for same product
- No product quality review process
- Specification drift without justification
- Customer complaints about product quality
- Supply chain disruptions impacting consistent delivery timelines
Auditor Tips
Product realisation means consistently manufacturing products that meet all quality attributes defined in regulatory filings. The PQS must ensure every batch meets specifications, from raw materials through final release.
Objective Evidence
- Knowledge management system or database
- Technology transfer protocols and reports
- Development-to-manufacturing knowledge packages
- Lessons learned from deviations and CAPAs
- Process understanding documents (design space, CPPs, CQAs)
- Prior knowledge assessments
- Knowledge sharing mechanisms (communities of practice)
- Retirement/succession knowledge capture plans
- Product lifecycle knowledge maps
Common Nonconformities
- No systematic knowledge capture process
- Knowledge lost during personnel changes
- Technology transfer without formal knowledge packages
- No lessons learned program
- Process understanding limited to validation reports
- Tacit knowledge of retiring subject matter experts not captured before departure
Auditor Tips
Knowledge management must cover the entire product lifecycle. Organizations must have systems to capture, store, retrieve, and share product and process knowledge. This includes tacit knowledge from experienced personnel, not just documented procedures.
Objective Evidence
- Organizational chart showing quality function
- Quality unit authority and independence documentation
- Role descriptions with quality responsibilities
- Reporting line documentation for quality escalation
- Resource allocation records for PQS activities
- Competency requirements for quality roles
- Delegation of authority matrix for quality decisions
Common Nonconformities
- Quality unit lacks independence from production
- Quality responsibilities not in job descriptions
- Inadequate staffing for quality functions
- No clear reporting line to senior management for quality
- Quality unit budget cuts not assessed for PQS impact
- Cross-site quality responsibilities undefined in multi-site organizations
Auditor Tips
The organization chart must reflect quality responsibilities. The quality unit must have adequate authority and independence. Reporting lines must support escalation of quality issues to senior management.
Objective Evidence
- Quality policy statement within quality manual
- Policy approved and dated by senior management
- Policy referencing pharmaceutical quality and patient safety
- Evidence of policy review and update cycle
- Communication records showing policy dissemination to all sites
- Employee awareness assessment results for quality policy content
- Policy revision history log with change rationale
Common Nonconformities
- Quality policy absent from quality manual
- Policy is generic, not pharmaceutical-specific
- Policy not signed or dated by management
- Policy not communicated beyond quality department
- No mention of patient safety or product lifecycle in policy text
- Policy unchanged for multiple years despite significant operational changes
Auditor Tips
The quality policy must be included in or referenced by the quality manual. It should be specific to pharmaceutical manufacturing, not generic boilerplate. The policy should articulate commitments to patient safety, regulatory compliance, and continual improvement. Auditors should verify that the policy is communicated to all levels of the organization and that employees can describe how their work relates to it.
Objective Evidence
- PQS scope explicitly listing drug product operations
- All dosage forms and product types covered
- Packaging and labeling operations within PQS
- ICH Q8 compliance for drug product development
- Drug product lifecycle tracking within PQS
- Container closure system qualification records under PQS
- Stability program integration with product lifecycle management
Common Nonconformities
- Some dosage forms or product lines excluded from PQS
- Packaging/labeling operations managed outside PQS
- No ICH Q8 linkage in product development
- Combination products omitted from PQS scope without rationale
- Serialization and track-and-trace not governed by PQS
- No formal handoff between development and commercial PQS for new products
Auditor Tips
Drug product (finished dosage form) manufacturing, packaging, labeling, and testing must all be within PQS scope. ICH Q8 linkage ensures Quality by Design principles are integrated. Auditors should confirm that all dosage forms in the portfolio are explicitly listed, and that the PQS governs the full chain from formulation through distribution, including any outsourced packaging or labeling operations.
Objective Evidence
- Process validation lifecycle documentation
- Continued process verification (CPV) program
- Control strategy documents
- Process monitoring plans with alert/action limits
- Control charts and statistical process control (SPC)
- Environmental monitoring programs
- Equipment qualification and calibration records
- Risk assessments informing monitoring strategies
Common Nonconformities
- No ongoing process monitoring after validation
- Alert/action limits not defined or not responded to
- Validated state not maintained after changes
- No statistical trending of process parameters
- Risk management not linked to monitoring strategy
- Equipment requalification not triggered after major maintenance events
Auditor Tips
State of control means validated processes operating within established parameters, monitored continuously. Organizations must have systems to detect deviations from the controlled state and respond appropriately. Quality risk management informs what to monitor and how.
Objective Evidence
- Quality risk management SOPs referencing ICH Q9
- Risk assessment tools (FMEA, HACCP, fault tree analysis)
- Risk assessments for process changes
- Risk-based approaches to process monitoring
- Supplier risk assessments
- Risk communication records
- Risk review and update documentation
- Risk-based audit planning
- Risk registers with periodic reviews
Common Nonconformities
- Risk management limited to regulatory submissions only
- FMEA completed once and never updated
- No risk-based approach to change management
- Risk assessments not referenced in CAPA investigations
- No formal risk communication process
- Risk register reviews overdue by more than one assessment cycle
Auditor Tips
QRM per ICH Q9 must be integrated throughout the PQS. Risk assessments should inform process monitoring strategies, change control priorities, CAPA root cause analysis, and management review focus areas. Risk management should be proactive, not just reactive.
Objective Evidence
- PQS scope statement in quality manual
- Product and site coverage defined
- Lifecycle stages covered per product
- Exclusions documented with justification
- Scope revision records triggered by portfolio or site changes
- Contract manufacturing and outsourced activity coverage matrix
- Annual scope adequacy review minutes
Common Nonconformities
- No scope statement in quality manual
- Scope is vague or undefined
- Exclusions not justified
- Recently acquired sites or products not yet reflected in scope
- Outsourced activities omitted from PQS scope boundaries
- Scope statement has not been revised since original quality manual issuance
Auditor Tips
The scope section must clearly define boundaries: which products, sites, operations, and lifecycle stages are included. Any exclusions must be justified. Auditors should verify that the scope is updated when new products are launched, sites are acquired or divested, or contract manufacturing arrangements change. A stale scope creates blind spots where products or processes may operate outside PQS governance.
Objective Evidence
- Documented relationship between PQS and applicable GMP regulations
- GMP compliance demonstrated alongside ICH Q10 implementation
- Regulatory requirements matrix mapping GMP to ICH Q10
- Gap analysis between regional GMP and ICH Q10
- Evidence of ICH Q10 elements enhancing baseline GMP
- Site master file referencing both GMP and ICH Q10
- Training records demonstrating staff awareness of GMP-Q10 distinctions
Common Nonconformities
- ICH Q10 treated as replacement for GMP
- No documentation of GMP-Q10 relationship
- ICH Q10 implemented without baseline GMP compliance
- Confusion between GMP requirements and Q10 enhancements
- PIC/S or EU GMP annex updates not reflected in PQS alignment reviews
- Regional GMP deviations not cross-referenced against ICH Q10 expectations
Auditor Tips
ICH Q10 does NOT replace GMP — it builds on top of it. Organizations must be compliant with regional GMP (EU GMP, FDA cGMP, PIC/S, etc.) as the baseline, and use ICH Q10 to enhance their PQS beyond minimum GMP. The relationship between Q10 and regional GMP should be documented.
Objective Evidence
- Continual improvement program documentation
- Improvement project tracking and metrics
- Variability reduction initiatives
- Innovation pipeline for quality improvements
- PQS enhancement proposals and outcomes
- Trend analysis reports driving improvements
- Management review improvement actions
- Benchmarking studies
Common Nonconformities
- No formal continual improvement program
- Improvement is only reactive (post-CAPA)
- Same issues recurring without systemic improvement
- No metrics tracking improvement effectiveness
- Innovation not considered for quality systems
- Improvement initiatives limited to corrective actions with no proactive projects
Auditor Tips
Continual improvement must be systematic, not just reactive. Organizations should identify improvement opportunities from multiple data sources (CAPA, deviations, process data, complaints, audits) and implement changes that measurably reduce variability and enhance quality.
Objective Evidence
- PQS process interaction diagrams
- Process maps or flow charts in quality manual
- Input/output definitions for each PQS process
- Linkage descriptions between CAPA, change, monitoring, review
- Turtle diagrams for key processes
- Data flow diagrams between PQS elements and supporting IT systems
- Cross-functional SIPOC charts for core pharmaceutical processes
Common Nonconformities
- No process maps or interaction diagrams
- Processes listed but linkages not shown
- Process maps outdated or do not reflect current operations
- Critical handoffs between quality, production, and regulatory not depicted
- Feedback loops from CAPA and management review absent from process maps
- Outsourced process steps not shown in interaction diagrams
Auditor Tips
The quality manual must show how PQS processes interact — not just list them. Visual tools (process maps, flow charts, turtle diagrams) should show inputs, outputs, and linkages between processes like CAPA, change management, monitoring, and management review.
Objective Evidence
- Documentation of how PQS supports regulatory confidence
- Examples of science-based regulatory approaches enabled by PQS
- Risk-based approaches documented and shared with regulators
- Real-time release testing programs (where applicable)
- Post-approval change management protocols (ICH Q12 linkage)
- Regulatory interaction records demonstrating PQS maturity
- Established condition assessment reports leveraging PQS data
Common Nonconformities
- PQS not leveraged for any regulatory flexibility
- No science-based or risk-based approaches to regulatory submissions
- Purely compliance-driven quality system with no strategic value
- Post-approval change submissions lack PQS performance data to support risk arguments
- No mechanism to capture regulatory commitments and track fulfilment within PQS
- Regulatory inspection findings repeatedly cite same PQS gaps across cycles
Auditor Tips
A mature ICH Q10 implementation can enable enhanced regulatory approaches such as real-time release testing, reduced post-approval submissions, and science-based regulatory flexibility. The PQS should demonstrate how it supports regulatory confidence.
Objective Evidence
- Management responsibility section in quality manual
- Organizational chart showing quality-related roles
- Authority matrix for quality decisions
- Role descriptions referenced in quality manual
- Delegation of authority documentation
- Management review attendance records confirming executive participation
- Succession planning documents for key quality leadership roles
Common Nonconformities
- No management responsibility section in manual
- Responsibilities vague or undefined
- Organizational chart missing or outdated
- Authority for quality decisions not documented
- Senior management absent from management review meetings
- No contingency for quality decision authority when key personnel are unavailable
Auditor Tips
The quality manual must clearly define who is responsible for what within the PQS. This includes quality unit authority, production management responsibilities, and senior management obligations. Organizational charts should support these definitions.
Objective Evidence
- Management commitment statement
- Management participation in quality reviews (minutes/attendance)
- Resource allocation records for quality initiatives
- Organizational chart with quality roles defined
- Escalation procedures for quality issues
- Management presentations on quality performance
- Quality KPIs reviewed by senior management
- Annual quality plan approved by management
Common Nonconformities
- Management absent from quality reviews
- Quality function under-resourced
- No escalation pathway for critical quality issues
- Quality objectives not set by senior management
- Management only involved during regulatory inspections
- Quality budget reduced without risk assessment justification
Auditor Tips
Senior management must be visibly and actively engaged with the PQS, not merely approving documents. They must demonstrate commitment through resource allocation, participation in reviews, and championing improvement.
Objective Evidence
- Management participation in PQS design workshops
- Sign-off on PQS architecture and structure
- Management involvement in PQS implementation milestones
- Periodic PQS maintenance reviews with management attendance
- Management input into PQS improvement initiatives
- Steering committee charter for PQS governance
- Gap analysis reports reviewed and approved by senior leadership
Common Nonconformities
- PQS designed entirely by quality department without management input
- Management signs off without understanding PQS design
- No management involvement in PQS updates or changes
- PQS architecture unchanged despite organizational restructuring
- No documented management attendance at PQS milestone gate reviews
- PQS governance delegated entirely to mid-level managers
Auditor Tips
Senior management must be personally involved in PQS design decisions, not just approving what the quality department proposes. Evidence of participation in design workshops, implementation reviews, and ongoing PQS governance is expected.
Objective Evidence
- Management communications on quality (emails, town halls, newsletters)
- Management attendance at quality events and training
- Budget approvals for quality improvement projects
- Management walkabouts/gemba walks in production areas
- Quality integrated into performance evaluations
- Executive sponsorship records for CAPA initiatives
- Board-level quality performance reporting decks
Common Nonconformities
- Quality communication only flows from QA, not management
- Management prioritizes schedule/cost over quality
- No visible management engagement with quality activities
- Quality improvement projects chronically deferred for production targets
- Employee surveys indicate lack of management quality commitment
- No executive sponsor assigned to critical quality programs
Auditor Tips
Visible support means management actions that employees can observe: attending quality events, communicating quality priorities, allocating resources, and holding people accountable for quality. 'Tone at the top' must be demonstrable.
Objective Evidence
- Quality issue escalation SOP
- Escalation matrix with triggers and timeframes
- Records of escalated quality issues
- Timeliness metrics for quality escalations
- After-action reviews for escalated events
- Evidence that escalation pathway was used effectively
- Field alert and product recall notification logs
Common Nonconformities
- No formal escalation procedure
- Critical quality issues delayed in reaching management
- Escalation pathway exists on paper but not used
- Management unaware of significant quality events
- Batch disposition decisions made without escalation of OOS results
- No after-action review conducted following escalated safety events
Auditor Tips
A formal escalation process must exist with defined triggers, timeframes, and escalation levels. Critical quality issues (recalls, serious deviations, safety concerns) must reach senior management within defined timeframes.
Objective Evidence
- Role descriptions with quality-related responsibilities
- Authority matrix for quality decisions
- Organizational chart showing PQS-related units
- RACI matrix for key PQS processes
- Communication of roles and authorities (training records)
- Interrelationship diagrams between functional units
- Delegation of authority letters for batch release and deviation closure
Common Nonconformities
- Quality responsibilities missing from non-QA job descriptions
- Ambiguous authority for quality decisions (e.g., batch release)
- Interrelationships not defined between QA and production
- Roles documented but not communicated
- Conflicting authority between site quality head and corporate quality
- No designated person responsible for pharmacovigilance liaison
Auditor Tips
Every unit involved in the PQS must have clearly defined roles and authority. This includes quality, production, engineering, regulatory, supply chain, and any other function that impacts product quality. Interrelationships between units must be documented.
Objective Evidence
- Documented quality policy statement
- Evidence of policy communication (training records, postings)
- Policy references to regulatory compliance
- Policy references to continual improvement
- Periodic review records of quality policy
- Employee awareness of quality policy (interviews/surveys)
- Translation of quality policy into local languages for multi-site operations
Common Nonconformities
- Generic quality policy not specific to pharmaceutical manufacturing
- Policy not communicated to shop floor personnel
- Policy not reviewed since initial creation
- No reference to continual improvement
- Policy contradicts actual practices
- Quality policy does not address patient safety or product lifecycle
Auditor Tips
The quality policy must be more than a generic statement. It should specifically address pharmaceutical quality, regulatory compliance, and continual improvement commitment. It must be communicated to and understood by all personnel.
Objective Evidence
- Documented quality objectives (site and department level)
- Quality plans with timelines and responsibilities
- Quality objectives aligned with quality policy
- Departmental quality objectives derived from site objectives
- Progress tracking against quality objectives
- Communication records of quality objectives
- Annual product quality review targets linked to quality plan
Common Nonconformities
- Quality objectives not measurable
- Same objectives year after year with no progress
- Objectives not cascaded to department level
- No quality plan to achieve objectives
- Objectives not linked to quality policy
- No interim milestone reviews for multi-year quality initiatives
Auditor Tips
Quality objectives must be SMART (specific, measurable, achievable, relevant, time-bound) and cascaded throughout the organization. Quality plans should detail how objectives will be achieved, by whom, and by when.
Objective Evidence
- Resource allocation plans for quality operations
- Staffing levels assessment for quality functions
- Training and competency development budgets
- Capital investment in quality infrastructure
- Equipment and facility maintenance budgets
- Resource adequacy assessments
- Workforce planning for quality roles
Common Nonconformities
- Quality function chronically understaffed
- Equipment maintenance deferred due to budget
- Training programs cut or delayed
- Quality lab capacity insufficient for workload
- No resource planning for quality activities
- Critical analytical instrument qualification lapsed due to funding gaps
Auditor Tips
Resource management encompasses all types of resources needed for the PQS. Management must ensure that quality activities are not compromised by resource constraints. Resource adequacy should be periodically assessed.
Objective Evidence
- Communication procedures for quality information
- Quality escalation SOPs with defined timeframes
- Meeting minutes (quality councils, cross-functional)
- Quality bulletin boards or digital communications
- Shift handover procedures for quality issues
- Quality alert systems
- Town hall or all-hands quality updates
Common Nonconformities
- Quality issues not escalated in timely manner
- Shop floor unaware of quality decisions
- No formal escalation procedures
- Communication silos between departments
- Quality information only flows top-down
- Shift-to-shift handover omits pending quality holds
Auditor Tips
Communication must be bidirectional — top-down for policy/objectives and bottom-up for quality issues/escalations. Timeliness is critical for quality escalations that may affect product on the market.
Objective Evidence
- Management review procedure
- Management review meeting minutes
- Management review agenda with all required inputs
- Action items from management review with follow-up
- Trending data presented at management review
- External assessment results reviewed
- PQS effectiveness assessment
- Innovation and improvement proposals reviewed
- Management review schedule
Common Nonconformities
- Management review not conducted at defined frequency
- Required inputs not all covered
- No action items generated from review
- Action items not followed up
- Review is a rubber-stamp exercise
- External factors not considered
Auditor Tips
Management review is a formal governance mechanism. It must systematically evaluate PQS performance using defined inputs, and produce actionable outputs. Reviews should occur at a defined frequency (typically annual at minimum) and cover all required input topics.
Objective Evidence
- Regulatory inspection results summarized for management review
- Internal audit reports presented at management review
- External audit findings and responses tracked
- Trend analysis of audit findings over time
- CAPA status for inspection/audit observations
- Regulatory commitment tracker with completion milestones
- Customer and partner audit finding closure reports
Common Nonconformities
- Inspection results not presented at management review
- Repeat audit findings indicating unresolved issues
- No tracking of audit finding trends
- Overdue regulatory commitments not escalated to senior management
- Internal audit schedule coverage gaps for GMP-critical areas
- Audit findings downgraded in severity without documented rationale
Auditor Tips
All regulatory inspection outcomes, internal and external audit results, and periodic PQS assessments must be presented to and reviewed by management. Trends in findings should be analyzed across multiple inspection cycles to identify systemic weaknesses. Management must demonstrate awareness of open commitments made to regulatory authorities and track their timely closure.
Objective Evidence
- PQS self-assessment or maturity assessment records
- PQS effectiveness metrics and trends
- Gap analysis against ICH Q10 requirements
- PQS suitability assessment documented in management review
- Comparison against industry benchmarks
- Process capability indices (Cpk/Ppk) trend summaries feeding PQS review
- Third-party PQS maturity audit reports
Common Nonconformities
- PQS never assessed as a system (only individual processes reviewed)
- No PQS effectiveness metrics defined
- Assessment is superficial or check-the-box
- PQS maturity score stagnant across consecutive review periods
- No linkage between PQS assessment outcomes and improvement plans
- Lifecycle stage changes not triggering PQS re-evaluation
Auditor Tips
The PQS itself must be periodically assessed — not just product quality. This is a meta-review: Is the quality system working? Are processes effective? Are resources adequate? This feeds into Section 4 (PQS continual improvement).
Objective Evidence
- External factors assessment in management review agenda
- Regulatory intelligence reports
- Industry guidance updates reviewed
- Technology assessment and adoption roadmap
- Competitor recall or industry quality event analysis
- Pharmacopeial monograph change impact assessments
- Supply chain risk monitoring reports for critical raw materials
Common Nonconformities
- Management review agenda does not include external factors
- No regulatory intelligence monitoring process
- Significant regulatory changes missed
- ICH or WHO guideline revisions not assessed for site impact
- No supply chain disruption contingency reviewed by management
- Competitor product recalls in same therapeutic area not discussed
Auditor Tips
Management must monitor and discuss external factors that could impact the PQS: new regulations, updated guidelines, emerging science, technological advances, competitor recalls, supply chain disruptions. A structured horizon-scanning process should feed into management review so that the organization can proactively adapt its PQS before external changes become compliance gaps.
Objective Evidence
- CAPA metrics and trending in management review
- Change management summary and backlog status
- Process performance trending reports
- Process monitoring KPI dashboards
- Integration of all four PQS element outputs in review agenda
- Deviation rate categorization summaries by root cause type
- Annual product quality review conclusions feeding management review
Common Nonconformities
- Management review missing one or more PQS element outputs
- CAPA metrics not tracked or presented
- Change backlog growing without management awareness
- Process performance trends not compared against validated acceptance criteria
- Overdue CAPA items exceeding target closure dates without escalation
- Deviation recurrence data absent from management review package
Auditor Tips
The four PQS elements (monitoring, CAPA, change management, management review) must feed into management review. Key metrics: CAPA closure rates, change control backlogs, process capability trends, deviation rates.
Objective Evidence
- Outsourced activities management SOP
- Contract acceptor qualification records
- Quality agreements with contract organizations
- Supplier qualification and approval process
- Contract acceptor audit reports
- Performance monitoring metrics for outsourced activities
- Incoming material testing/verification records
- Supplier change notification agreements
- Outsourcing risk assessments
Common Nonconformities
- No quality agreements with contract organizations
- Contract acceptors not audited
- No incoming material testing or verification
- Outsourced activities not included in PQS scope
- No performance monitoring of contract acceptors
- Supplier change notifications not triggering impact assessment at contract giver
Auditor Tips
Outsourcing does not absolve the pharmaceutical company of quality responsibility. Robust qualification, monitoring, and oversight of contract organizations (CMOs, CROs, testing labs) must be maintained. Purchased materials must be controlled through qualified suppliers.
Objective Evidence
- Contract acceptor qualification procedure
- Pre-qualification audit reports
- Capability assessment documentation
- Regulatory inspection history of contract acceptor
- Approved supplier/contractor list
- Re-qualification schedule and records
- Risk-based classification of contract acceptors by GMP criticality
Common Nonconformities
- Outsourced activities started before qualification complete
- No on-site audit of contract acceptors performing GMP activities
- Qualification based solely on self-assessment questionnaire
- No re-qualification process
- Contract acceptor warning letters or consent decrees not reviewed before engagement
- Qualification dossier lacks evaluation of analytical method transfer readiness
Auditor Tips
Before outsourcing any GMP activity, the contract acceptor must be qualified. This includes on-site audits, capability assessment, regulatory history review, and documented approval. Re-qualification should occur periodically.
Objective Evidence
- Quality agreements with defined responsibilities
- Communication protocols for quality issues
- Deviation notification requirements and timeframes
- Change notification agreements
- Complaint and recall coordination procedures
- Regular quality review meetings with contractors
- Joint investigation reports for shared root cause deviations
Common Nonconformities
- Quality agreement missing or incomplete
- No defined process for deviation notification from contractor
- Changes at contractor not communicated to contract giver
- No regular quality review meetings
- Out-of-specification results at CMO not reported within contractual timeframes
- Annual product quality review data from contract acceptor not obtained
Auditor Tips
Quality agreements must clearly define who does what, how quality issues are communicated, and what the escalation process is. This includes deviation notification, change notification, complaint handling, and recall coordination.
Objective Evidence
- Contractor performance KPIs and scorecard
- Periodic performance review records
- Deviation rate trending for outsourced activities
- CAPA effectiveness at contractor sites
- Improvement action plans for underperforming contractors
- De-qualification criteria and process
- Comparative benchmarking across multiple contract sites for same service
Common Nonconformities
- No ongoing performance monitoring of contractors
- Performance data collected but not acted upon
- Same quality issues recurring at contractor without improvement
- No defined criteria for contractor de-qualification
- Batch rejection rate at contract site trending upward without corrective action
- Contractor re-audit findings not tracked through to verified closure
Auditor Tips
Ongoing performance monitoring is required — qualification alone is not sufficient. KPIs should track quality, timeliness, deviation rates, and CAPA effectiveness at the contractor. Poor performance must trigger improvement actions or de-qualification.
Objective Evidence
- Product lifecycle management framework
- Stage-specific quality plans
- Technology transfer protocols
- Product discontinuation procedures
- Lifecycle risk assessments
- Stage gate criteria for lifecycle transitions
- Cross-functional lifecycle governance committee charter
Common Nonconformities
- No lifecycle approach to product quality
- Technology transfer treated as one-time event
- No product discontinuation planning
- Same quality approach for all lifecycle stages
- Post-approval lifecycle activities not linked to development knowledge
- No formal stage gate reviews between lifecycle phases
Auditor Tips
The PQS must address all four lifecycle stages. Goals for each stage inform what PQS elements (CAPA, change management, monitoring, review) need to focus on. Products at different lifecycle stages have different quality risks and knowledge levels.
Objective Evidence
- PQS description showing four elements and their interactions
- Process interaction diagrams
- Data flow between PQS elements
- Integrated quality metrics covering all four elements
- Documented escalation pathways from monitoring to CAPA to change control
- Procedure describing how management review outputs feed back into PQS elements
- Cross-element performance dashboard or summary report
Common Nonconformities
- PQS elements operate in silos
- No integration between monitoring, CAPA, change, and review
- Missing one or more PQS elements entirely
- CAPA outputs not feeding into change management system
- Management review does not reference process monitoring data
- No documented linkage between monitoring signals and CAPA initiation criteria
Auditor Tips
The four PQS elements are the operational backbone of ICH Q10. They must work as an integrated system, not as isolated processes. Output from one element feeds into others (e.g., monitoring triggers CAPA, CAPA drives change management, all reviewed in management review).
Objective Evidence
- Pharmaceutical development reports (per ICH Q8)
- Quality Target Product Profile (QTPP)
- Critical Quality Attributes (CQA) identification
- Design of Experiments (DoE) studies
- Control strategy based on process understanding
- Design space definition (where applicable)
- Risk assessments during development
- Development knowledge transfer documents
Common Nonconformities
- No systematic approach to development
- CQAs not identified or justified
- Control strategy not based on process understanding
- Development knowledge not captured for transfer
- No formal linkage between CQAs and process design decisions
- Risk assessments from development not updated through clinical phases
Auditor Tips
Development must use Quality by Design (QbD) principles where applicable. Product and process understanding gained during development forms the foundation for commercial manufacturing control strategy.
Objective Evidence
- Process monitoring SOPs
- Statistical process control (SPC) charts and programs
- Process Analytical Technology (PAT) implementation
- Continued Process Verification (CPV) protocols
- Product quality trending reports
- Control charts with alert and action limits
- Environmental monitoring trending
- Stability trending data
- Process capability indices (Cpk)
- Feedback/feedforward process adjustments
Common Nonconformities
- No ongoing process monitoring program
- SPC charts maintained but not reviewed or acted upon
- Alert limits breached without investigation
- No risk-based approach to monitoring frequency
- Monitoring data not trended or analyzed
- Environmental monitoring excursions not escalated per defined criteria
Auditor Tips
This is the ongoing vigilance system for process and product quality. It combines statistical tools (SPC, PAT), risk-based monitoring strategies, and feedback/feedforward loops. Monitoring should be proactive, not just reactive detection of failures.
Objective Evidence
- CQA identification and justification documents
- Risk assessment linking CQAs to patient impact
- CQA criticality analysis (e.g., FMEA for quality attributes)
- CQA list linked to specifications and control strategy
- Periodic CQA review as knowledge grows
- FMEA or risk ranking worksheets for quality attribute prioritization
- Traceability matrix linking CQAs to clinical performance endpoints
Common Nonconformities
- CQAs not formally identified
- No justification for CQA designation
- CQAs identified but not linked to control strategy
- CQA list never updated as process knowledge evolves
- Criticality designations copied from predicate products without product-specific evaluation
- No documented rationale for attributes excluded from CQA list
Auditor Tips
CQAs must be identified through systematic scientific evaluation, not assumed. The justification for each CQA (and for attributes not designated as critical) should be documented. CQAs link directly to patient safety and efficacy.
Objective Evidence
- Risk assessment driving monitoring strategy
- Monitoring parameters justified by risk analysis
- Alert and action limits with risk-based rationale
- Monitoring frequency justified by risk level
- Periodic review of monitoring strategy adequacy
- FMEA or hazard analysis used to prioritize monitored parameters
- Documented acceptance criteria for alert and action limit derivation
Common Nonconformities
- Monitoring parameters chosen arbitrarily, not risk-based
- No alert/action limits defined
- Same monitoring frequency for all parameters regardless of risk
- Risk assessment for monitoring strategy not updated after process changes
- Critical process parameters excluded from routine monitoring without justification
- Alert limits set at specification limits rather than tighter process capability boundaries
Auditor Tips
Monitoring strategy must be risk-informed. High-risk parameters need tighter monitoring frequency and limits. Risk assessments should justify what is monitored, how often, and what constitutes an alert vs. action.
Objective Evidence
- Control strategy document linking CPPs to CQAs
- Process parameter ranges and proven acceptable ranges
- Design space definition (where applicable)
- Control strategy review and updates as knowledge grows
- Technology transfer of control strategy to manufacturing
- Multivariate interaction studies supporting CPP range selection
- Scale-up risk assessment for control strategy applicability
Common Nonconformities
- No documented control strategy
- Control strategy not linked to CPP-CQA relationships
- Control strategy not transferred to manufacturing
- No updates to control strategy post-development
- Proven acceptable ranges not supported by experimental data
- Control strategy relies solely on end-product testing without in-process controls
Auditor Tips
The control strategy must bridge development and manufacturing. It defines how CPPs are controlled to ensure CQAs are met. This is the primary deliverable of QbD that carries into commercial manufacturing.
Objective Evidence
- SPC program with control charts for key parameters
- PAT implementation where applicable
- Statistical trending analysis reports
- Training records for SPC/PAT practitioners
- Tool selection rationale based on process characteristics
- Capability study reports (Cpk/Ppk calculations) for monitored parameters
- Out-of-trend investigation records triggered by SPC rule violations
Common Nonconformities
- Data collected but no statistical analysis performed
- SPC charts generated but not reviewed or acted upon
- No appropriate monitoring tools for critical processes
- Western Electric or Nelson rules not applied to control charts
- PAT instruments not calibrated or qualified per established schedule
- Statistical methods applied without verification of underlying data distribution assumptions
Auditor Tips
Appropriate statistical or analytical tools must be deployed. SPC charts, PAT instruments, and trending analysis should be used based on the nature of the process. Raw data collection without statistical analysis is insufficient.
Objective Evidence
- Technology transfer protocols and reports
- Transfer acceptance criteria
- Knowledge package documentation
- Receiving site process validation
- Gap analysis between development and manufacturing
- Comparability studies
- Training records for receiving site
- Transfer risk assessments
Common Nonconformities
- Technology transfer without formal protocol
- No acceptance criteria for successful transfer
- Knowledge gaps between development and manufacturing
- Receiving site unable to reproduce development results
- Critical process parameters not clearly identified in transfer package
- No formal gap closure mechanism when receiving site identifies knowledge deficiencies
Auditor Tips
Technology transfer is not just moving documents — it requires comprehensive knowledge transfer verified through successful process execution at the receiving site. The knowledge transferred should be sufficient to establish and maintain a state of control.
Objective Evidence
- Feedback loops documented for key process parameters
- Feedforward controls based on incoming material attributes
- Proactive process adjustment procedures
- Examples of trend-based corrective actions taken before failure
- Process adjustment records linked to monitoring data
- Feedforward adjustment criteria based on raw material lot variability
- Documented decision trees for operator-initiated process corrections
Common Nonconformities
- Monitoring is passive — data collected but no feedback mechanism
- No proactive response to trends approaching limits
- Feedback loops exist only for automated systems, not manual processes
- Incoming material variability not used for feedforward parameter adjustment
- Process adjustments made ad hoc without documented criteria
- No evidence of trend-based interventions preventing OOS results
Auditor Tips
Process monitoring must close the loop: monitoring data should trigger corrective adjustments (feedback) and predictive adjustments (feedforward). Proactive means acting on trends before out-of-specification occurs.
Objective Evidence
- Manufacturing SOPs and batch records
- Process validation and continued process verification
- Annual Product Review / Product Quality Review
- Process monitoring data and trending
- Deviation and CAPA trending
- Change control records
- Batch disposition records
- Environmental monitoring data
- Equipment qualification and calibration
Common Nonconformities
- No ongoing process monitoring after validation
- No annual product review
- Process improvements not implemented
- Knowledge from manufacturing not captured
- Continued process verification program absent or inactive
- Batch disposition decisions not linked to in-process monitoring results
Auditor Tips
Commercial manufacturing is where the PQS is most actively applied. All four PQS elements (CAPA, change management, process monitoring, management review) must work together to maintain quality during routine production.
Objective Evidence
- CAPA SOP
- CAPA records with root cause analysis
- Root cause analysis tools (5-Why, fishbone, fault tree)
- CAPA effectiveness checks
- CAPA trending and metrics
- Sources of CAPA input (complaints, deviations, audits, etc.)
- Risk-based categorization of CAPA events
- CAPA timeliness metrics
- Cross-product/process impact assessments
- CAPA closure documentation
Common Nonconformities
- Root cause analysis superficial (e.g., always 'human error')
- No effectiveness checks performed
- CAPA backlog growing without resolution
- Same root causes recurring
- CAPA not triggered by audit or inspection findings
- No trending of CAPA data
Auditor Tips
The CAPA system is the engine of improvement. It must be fed by multiple sources (not just deviations), use root cause analysis, and include effectiveness verification. CAPAs should be risk-proportionate — not every event needs a full investigation.
Objective Evidence
- APR/PQR procedure
- Completed APR/PQR reports for each product
- Batch data trending (yield, impurities, dissolution)
- Process capability indices (Cpk, Ppk) in APR
- Deviation and OOS trending in APR
- Stability data review in APR
- Complaint trending in APR
- CAPA actions generated from APR findings
Common Nonconformities
- No APR/PQR performed
- APR/PQR performed but no trending analysis
- No CAPA actions from APR findings
- Process capability declining without investigation
- APR completed late (beyond regulatory timeframes)
- Stability data omitted from annual review scope
Auditor Tips
APR/PQR is a mandatory periodic review of all batches manufactured during the review period. It must cover: batch results, deviations, changes, stability data, complaints, returns, recalls, OOS/OOT results, and process capability. Trending must identify emerging issues.
Objective Evidence
- CAPA source categories defined in procedure
- Evidence of CAPAs initiated from each source type
- Trending analysis across multiple CAPA sources
- Audit/inspection findings converted to CAPAs
- Complaint-driven CAPAs
- Process monitoring trend-driven CAPAs
- Management review action items escalated to CAPA when systemic
Common Nonconformities
- CAPAs only triggered by deviations, other sources ignored
- Audit findings not tracked through CAPA system
- No trend-driven CAPAs (only reactive)
- Complaints handled outside CAPA system
- Stability OOT signals not escalated to CAPA evaluation
- Process monitoring trend excursions not linked to CAPA initiation
Auditor Tips
CAPA must not be limited to deviations alone. All quality data sources must feed into the CAPA system. Trending of multiple data sources should identify systemic issues that individual events do not reveal.
Objective Evidence
- CPV program procedure
- CPV protocols for each product/process
- Statistical monitoring plans (SPC, trend analysis)
- Control charts for CPPs and CQAs
- CPV periodic reports with trend assessment
- Trigger criteria for process revalidation
- CPV-driven improvement actions
Common Nonconformities
- No CPV program after process validation
- CPV exists but no statistical analysis
- Control chart signals not investigated
- Process monitoring stopped after initial validation
- No documented trigger criteria for revalidation based on CPV signals
- Intra-batch variability not captured in monitoring plan
Auditor Tips
CPV is Stage 3 of the FDA process validation lifecycle. It must use statistical tools to monitor process parameters and quality attributes on an ongoing basis. CPV complements but does not replace APR/PQR.
Objective Evidence
- Root cause analysis tools defined in CAPA procedure
- Completed root cause analyses using structured tools
- Training records for investigation personnel on RCA tools
- Evidence of going beyond 'human error' to systemic causes
- Investigation reports with tool selection rationale
- Causal factor charting or barrier analysis records
- Investigation timeliness tracking against SOP-defined deadlines
Common Nonconformities
- Root cause listed as 'human error' without further analysis
- No structured RCA tools used
- Investigations superficial or incomplete
- Same root causes recurring (indicating ineffective RCA)
- Investigation timelines repeatedly exceed procedure-defined targets
- No evaluation of contributing factors beyond the immediate root cause
Auditor Tips
Root cause analysis must use structured tools (5-Why, fishbone/Ishikawa, fault tree analysis, etc.), not just narrative descriptions. 'Human error' as a root cause is almost always insufficient — the investigation should identify why the human error occurred (system, training, design).
Objective Evidence
- Product discontinuation procedure
- Product discontinuation plan (product-specific)
- Retained sample management post-discontinuation
- Stability monitoring continuation plan
- Complaint handling continuation plan
- Regulatory notification records
- Document retention schedule compliance
Common Nonconformities
- No product discontinuation procedure
- Stability monitoring stopped prematurely
- Retained samples destroyed before retention period
- No plan for ongoing complaint handling
- Supply chain notification to downstream customers not documented
- Recall-readiness plan not maintained through discontinuation
Auditor Tips
Product discontinuation must be planned and managed. Key obligations continue after manufacturing ceases: stability monitoring, complaint handling, regulatory reporting, and document retention must continue for the required retention periods.
Objective Evidence
- CAPA risk categorization procedure
- Evidence of risk-based investigation depth
- Critical events with comprehensive investigations
- Low-risk events with proportionate assessments
- Risk categorization criteria documented
- Investigation template tiers aligned to risk category
- Documented examples of abbreviated assessments for low-risk events
Common Nonconformities
- Same investigation depth for all events regardless of risk
- High-risk events with shallow investigations
- No risk categorization for CAPA events
- Low-risk events subjected to full investigation causing resource diversion
- Risk categorization performed after investigation instead of before
- No documented criteria distinguishing investigation tiers
Auditor Tips
Not every CAPA needs a full-scale investigation. Risk categorization should drive investigation depth: critical events need formal root cause analysis with full documentation, while low-risk events may need only basic assessment. The categorization system must be documented.
Objective Evidence
- Cross-product/process impact assessment in CAPA records
- Horizontal deployment of corrective actions
- Impact assessment procedure for multi-product applicability
- Evidence of actions extended to other affected products/sites
- Cross-site applicability assessment for multi-plant operations
- Shared-equipment or shared-material impact evaluation records
- Horizontal deployment tracking log with completion dates
Common Nonconformities
- Impact assessment limited to the specific product/process involved
- No horizontal deployment of corrective actions
- Recurring same-root-cause events across different products
- Multi-site operations with no cross-site CAPA communication protocol
- Shared raw material or excipient suppliers not evaluated during impact assessment
- Contract manufacturing sites excluded from cross-product reviews
Auditor Tips
Every investigation must assess whether the root cause could affect other products, processes, or sites. This is critical for preventing the same failure mode from occurring elsewhere in the organization.
Objective Evidence
- Effectiveness check criteria defined at CAPA initiation
- Completed effectiveness verification records
- Timeframe for effectiveness check documented
- Evidence that unintended consequences were assessed
- Failed effectiveness checks leading to revised CAPAs
- Statistical before-and-after comparison data for key metrics
- Documented timeframe rationale for when effectiveness check is due
Common Nonconformities
- No effectiveness checks performed
- Effectiveness checks are rubber-stamp approvals
- Same issue recurs after CAPA closure (indicating ineffective CAPA)
- No assessment for unintended consequences
- Effectiveness check performed immediately after implementation without allowing sufficient data accumulation
- No re-opened CAPA records despite known recurring issues
Auditor Tips
Every CAPA must include a planned effectiveness check. The check must occur after sufficient time/data to evaluate whether the action worked. It must also verify no unintended consequences were introduced.
Objective Evidence
- Change management/change control SOP
- Change request forms and approvals
- Impact assessments (quality, regulatory, process)
- Risk assessments for proposed changes
- Expert review documentation
- Post-implementation review records
- Regulatory assessment of changes (variation classification)
- Change effectiveness evaluation
- Change trending reports
- Change categorization (minor/major/critical)
Common Nonconformities
- Changes implemented without formal approval
- No risk assessment for changes
- Post-implementation reviews not conducted
- Regulatory impact not assessed
- Change backlog growing without resolution
- No categorization of changes by risk
Auditor Tips
Change management must be structured, risk-based, and include post-implementation review. Changes can be driven by CAPA, process improvement, innovation, or regulatory requirements. All changes must be evaluated for regulatory impact (marketing authorisation).
Objective Evidence
- Risk assessment procedure for change evaluation
- Completed risk assessments for proposed changes
- Risk-based change categorization (minor/major/critical)
- Evidence of risk assessment informing change decision
- Risk mitigation plans for high-risk changes
- Change risk scoring matrix linking severity and likelihood
- Escalation thresholds defining which changes require senior management approval
Common Nonconformities
- Changes approved without risk assessment
- Risk assessment is pro-forma with no real evaluation
- No risk-based categorization of changes
- High-risk changes approved at same authority level as minor changes
- Risk assessment does not consider impact on validated state
- No stability assessment required for formulation or process changes
Auditor Tips
Every proposed change must be risk-assessed before approval. The risk assessment should evaluate impact on product quality, validated state, stability, and supply chain. Higher-risk changes need more rigorous evaluation and controls.
Objective Evidence
- Regulatory impact assessment in change records
- Variation classification (Type IA, IB, II or US equivalent)
- Regulatory affairs review of proposed changes
- Filing decisions documented with rationale
- Post-approval change management protocol (PACMP) where applicable
- Comparability protocol outcomes for post-approval analytical method changes
- Regulatory submission tracking log linked to change control records
Common Nonconformities
- Changes implemented without regulatory impact assessment
- Regulatory affairs not consulted on process changes
- Changes requiring filings made without submissions
- Variation classification not documented or inconsistent across similar changes
- No tracking of pending regulatory submissions tied to implemented changes
- Annual report or periodic safety update obligations missed for process changes
Auditor Tips
Every change must be evaluated for regulatory impact: does it require a variation/supplement, annual report notification, or no filing? This assessment must be documented and should involve regulatory affairs.
Objective Evidence
- Cross-functional change review board or team
- Expert review signatures on change records
- Meeting minutes from change review discussions
- Discipline-specific impact assessments
- Expert reviewer qualifications documented
- Validation and stability SME sign-off records for process changes
- Escalation criteria for engaging external subject matter experts
Common Nonconformities
- Changes reviewed only by initiating department
- No cross-functional review process
- Expert reviewers lack relevant qualifications
- Validation team not included in review of process parameter changes
- Stability function not consulted on packaging or storage condition changes
- No documented criteria for which disciplines must review each change category
Auditor Tips
Change review must be cross-functional, not limited to the initiating department. Relevant experts (QA, production, engineering, regulatory, validation, stability) must evaluate each change within their domain.
Objective Evidence
- Post-implementation review procedure
- Completed post-implementation review records
- Data analysis comparing pre- and post-change performance
- Confirmation that change objectives were met
- Assessment of unintended consequences
- Number of batches or time period for review defined
- Stability data comparison before and after the implemented change
Common Nonconformities
- No post-implementation reviews conducted
- Reviews conducted but no data analysis
- Unintended consequences not assessed
- Changes closed without confirming objectives met
- Minimum batch count for post-implementation evaluation not defined in procedure
- Post-implementation review delayed beyond defined timeframe without justification
Auditor Tips
After a change is implemented, a post-implementation review must verify that it achieved its objectives and did not introduce unintended consequences. The review should include data analysis over an appropriate number of batches or time period.
Objective Evidence
- Management review procedure specific to PQS
- Management review meeting minutes and records
- PQS performance KPIs and dashboards
- Quality metrics reports (complaints, recalls, deviations, CAPA)
- Process performance trending presented to management
- Product quality trending presented to management
- Regulatory inspection history and status
- Action items from management review with follow-up
- Management review schedule and attendance records
Common Nonconformities
- Management reviews skipped or delayed
- KPIs not defined or not measured
- No action items generated
- Same issues discussed repeatedly without resolution
- Management review does not cover all PQS elements
- Action items from prior reviews not tracked to closure
Auditor Tips
This is the detailed management review requirement specific to process performance and product quality (complementing the broader Section 2.6 management review). It requires specific KPIs and metrics covering all PQS elements to be reviewed by management.
Objective Evidence
- Quality objectives scorecard in management review
- Target vs. actual performance for each objective
- Trend of objective achievement over time
- Action plans for objectives not met
- Revised objectives based on review outcomes
- Site-level and corporate-level objective alignment evidence
- Documented escalation when objectives are missed for consecutive periods
Common Nonconformities
- Quality objectives not measured or tracked
- No target vs. actual comparison
- Objectives always met (targets too easy)
- Objectives never met (targets unrealistic, no action taken)
- Objectives not cascaded from corporate quality policy to site-level metrics
- No management action plans documented when objectives are missed
Auditor Tips
The management review must include a formal assessment of whether quality objectives (set per Section 2.3) have been met. This requires measurable objectives with defined targets and actual performance data.
Objective Evidence
- Defined KPI set for PQS effectiveness
- KPI dashboard or report for management review
- Complaint rate and trending
- Deviation rate and categorization trending
- CAPA metrics (open, overdue, closure rate, effectiveness rate)
- Change control metrics (backlog, approval time)
- Product quality trending (batch pass rate, Cpk, stability)
- Regulatory inspection status and finding trends
Common Nonconformities
- No defined KPIs for PQS
- KPIs collected but not trended or analyzed
- Management review without quantitative performance data
- KPIs all showing positive when quality issues persist
- Recall and field alert metrics absent from management review package
- No benchmarking of KPIs against industry or internal site comparisons
Auditor Tips
A defined set of KPIs must be tracked and presented at management review. These should cover all aspects of the PQS: complaints (rate, trending), recalls, deviation rates, CAPA metrics (open, overdue, effectiveness), change control metrics, product quality trends, and regulatory status.
Get the Full 78-Item Checklist
Download the complete ICH Q10 audit checklist with all 78 expert items, objective evidence requirements, common nonconformities, auditor tips, and a professional scoring rubric.
This checklist is an educational resource for audit preparation. It does not constitute professional regulatory advice. Always consult qualified auditors for certification decisions.