Product Quality Review: Complete Guide for Pharmaceutical Quality Teams

A product quality review (PQR) is a comprehensive, periodic evaluation of all manufactured pharmaceutical products to verify process consistency, identify improvement opportunities, and ensure continued process validation. Required by ICH Q10 and regulatory authorities worldwide, PQRs form the backbone of pharmaceutical quality oversight.

Quality directors and QA managers face a critical challenge: regulatory authorities expect systematic product quality reviews, but most teams struggle with data aggregation, trend analysis across multiple systems, and timely completion within prescribed annual cycles.

The consequences of inadequate product quality reviews are severe. FDA warning letters frequently cite incomplete PQRs, missed trending signals, and failure to investigate adverse quality patterns. EMA inspections increasingly focus on PQR depth and the effectiveness of continuous improvement actions stemming from review findings.

In this guide, you'll learn:

• Product quality review requirements under ICH Q10, FDA, and EMA regulations
• Step-by-step PQR implementation process for pharmaceutical quality systems
• Key metrics and data sources required for comprehensive quality review reports
• Common PQR deficiencies cited in regulatory inspections and how to avoid them
• Tools and systems for automating product quality review data collection
• Best practices from quality leaders at biotech and pharma companies

What Is a Product Quality Review? [Complete Definition]

A product quality review (PQR) is a documented, comprehensive evaluation of all aspects of pharmaceutical product manufacturing and control performed at regular intervals, typically annually. The PQR assesses whether current manufacturing processes remain in a state of control and identifies trends that may indicate potential quality issues before they result in product failures or patient harm.

Key characteristics of pharmaceutical product quality reviews:

• Comprehensive scope - PQRs must evaluate all manufactured products, including commercial batches, clinical supplies, and validation batches produced during the review period
• Multi-source data integration - Effective PQRs combine data from batch records, deviation investigations, change controls, stability programs, customer complaints, and returned products
• Regulatory requirement - ICH Q10 mandates PQRs as part of pharmaceutical quality systems, with specific requirements detailed in EU GMP Chapter 1 and FDA Process Validation Guidance
• Action-oriented outcomes - PQRs must result in documented conclusions and, where appropriate, corrective and preventive actions (CAPA) to address identified trends

The product quality review differs from batch release review, which focuses on individual batch acceptance. While batch review asks "is this specific batch acceptable?", the PQR asks "is our overall manufacturing process performing as expected across all batches?"

Regulatory basis for product quality reviews:

ICH Q10 Product Quality Review Requirements

The International Council for Harmonisation (ICH) Q10 guideline establishes the pharmaceutical quality system framework that includes product quality review as a core element. ICH Q10 positions the PQR within the "management review" component of quality systems, emphasizing its role in ensuring continuous improvement and knowledge management.

ICH Q10 PQR Scope Requirements

ICH Q10 specifies that product quality reviews should evaluate:

Process performance indicators:

• Critical process parameter trending and control chart analysis
• In-process control results compared to acceptance criteria
• Manufacturing yield variations and material utilization efficiency
• Equipment performance metrics and downtime patterns
• Environmental monitoring trends for controlled manufacturing areas

Product quality indicators:

• Finished product testing results trending (release and stability)
• Out-of-specification (OOS) and out-of-trend (OOT) investigations
• Stability program results including ongoing and accelerated studies
• Reprocessing and rework frequency and impact assessment
• Post-approval changes affecting product quality attributes

Quality system effectiveness:

• Deviation and investigation trends by category, product, and process
• Change control implementation patterns and post-change effectiveness
• Corrective and preventive action (CAPA) closure rates and recurrence
• Supplier quality performance and raw material variability
• Customer complaints and adverse event patterns

PQR Pharmaceutical Implementation Under ICH Q10

ICH Q10 emphasizes that product quality reviews should not be merely retrospective data compilations. Instead, effective PQRs:

1. Identify improvement opportunities - The review process should uncover areas where enhanced process understanding, control strategies, or quality risk management could benefit product quality or manufacturing efficiency
2. Support knowledge management - PQR findings contribute to the pharmaceutical development knowledge space, informing scale-up, technology transfer, and lifecycle management decisions
3. Enable science-based decisions - Quality review data should drive continuous improvement initiatives based on statistical analysis and process capability assessment rather than reactive problem-solving
4. Demonstrate regulatory commitment - The depth and rigor of product quality reviews signal to inspectors that senior management actively oversees quality performance

Product Quality Review EMA Expectations

The European Medicines Agency (EMA) provides the most detailed and prescriptive product quality review requirements globally through EU GMP Part I, Chapter 1. EMA expectations have evolved significantly, particularly following the 2015 revision that expanded PQR scope and clarified annual review obligations.

EMA Product Quality Review Scope

EU GMP Chapter 1 mandates that product quality reviews include:

Product Quality Review Report Structure (EMA Model)

EMA inspectors expect PQR reports to follow a logical structure that facilitates regulatory review:

Section 1: Executive Summary

• Review period and products covered
• Overall quality performance assessment
• Critical findings requiring management attention
• Status of actions from prior reviews

Section 2: Product and Process Overview

• Manufacturing sites and responsibilities
• Process description and critical quality attributes
• Control strategy summary
• Batch volume and commercial status

Section 3: Data Analysis

• Statistical evaluation of each review element
• Trend charts with control limits
• Comparative analysis (year-over-year, product-to-product)
• Investigation summaries for anomalous results

Section 4: Conclusions and Actions

• Assessment of process state of control
• Identified improvement opportunities
• Required CAPAs with owners and timelines
• Regulatory notification needs (if changes impact marketing authorization)

Section 5: Approval

• QA leadership review and approval
• Manufacturing leadership concurrence
• Senior management sign-off

FDA Product Quality Review Expectations

While FDA regulations do not explicitly require annual product quality reviews by name, the agency's Process Validation Guidance (2011) establishes clear expectations for ongoing process performance monitoring that effectively mandate PQR-equivalent activities.

FDA Stage 3 Process Validation and Quality Review

FDA's Process Validation Guidance divides validation into three stages:

• Stage 1: Process Design
• Stage 2: Process Qualification
• Stage 3: Continued Process Verification

Stage 3 requirements align closely with product quality review principles:

FDA expectations for continued process verification:

• Continuous monitoring - Collect and evaluate data on manufacturing process performance and product quality throughout the lifecycle
• Statistical trending - Use control charts and capability metrics to detect meaningful shifts in process performance
• Periodic evaluation - Conduct formal reviews at appropriate intervals to assess whether the process remains in a state of control
• Investigation protocols - Define OOS, OOT, and adverse trend thresholds that trigger investigation
• Corrective action - Implement improvements when data indicate process drift or capability concerns

Key Differences: FDA vs EMA PQR Approach

Despite these differences, FDA inspections increasingly scrutinize whether companies conduct comprehensive quality reviews. Recent warning letters cite:

• Failure to investigate adverse quality trends identified through ongoing monitoring
• Lack of documented periodic review of process performance data
• Inadequate follow-up on CAPA effectiveness from previous investigations
• Missing management oversight of quality performance indicators

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Compliance Strategy: Even without explicit FDA requirements for annual PQRs, implementing EMA-aligned product quality reviews provides robust evidence of Stage 3 continued process verification compliance during FDA inspections.

Essential Elements of a Comprehensive PQR

A quality review report must synthesize data from multiple systems into actionable intelligence. The most effective product quality reviews go beyond mere data compilation to provide statistical analysis, trend identification, and evidence-based recommendations.

1. Manufacturing Performance Metrics

Batch production statistics:

• Total batches manufactured during review period (by product, strength, site)
• Manufacturing success rate (first-time-right percentage)
• Yield analysis with statistical limits and investigation thresholds
• Rejected batches with root cause categorization
• Reprocessing and rework frequency with quality impact assessment

Process parameter trending:

• Critical process parameters plotted against specification limits
• Process capability indices (Cp, Cpk) for key manufacturing steps
• Control chart analysis (X-bar, R-chart, individuals control charts)
• Multivariate analysis for processes with interdependent parameters
• Comparison to historical performance and validation ranges

Equipment performance indicators:

• Equipment qualification status and requalification schedules
• Downtime analysis by equipment type and failure mode
• Preventive maintenance compliance and effectiveness
• Calibration program compliance and out-of-tolerance findings
• Environmental monitoring trends (temperature, humidity, particle counts, viable organisms)

2. Product Quality Performance

Release testing analysis:

Stability program review:

• Ongoing stability results vs shelf-life specifications
• Accelerated stability trends and extrapolation to real-time
• Photostability and stress testing outcomes
• Retest dating for intermediates and API
• Container-closure system compatibility assessment
• Comparative stability across manufacturing sites or process changes

Out-of-specification investigations:

• Total OOS events by product, test method, and manufacturing stage
• Laboratory error vs true OOS categorization
• Assignable cause identification rate and CAPA effectiveness
• Recurrence of similar OOS events (indicating systemic issues)
• Time to investigation completion and regulatory notification compliance

3. Quality System Performance Indicators

Deviation trending:

The PQR should analyze manufacturing deviations across multiple dimensions:

• By category: Process deviation, equipment malfunction, documentation error, material issue, laboratory deviation, environmental excursion
• By severity: Critical (product impact likely), major (product impact possible), minor (no product impact)
• By product/process: Identifying if specific products or unit operations generate disproportionate deviations
• By root cause: Determining if systemic factors (procedure inadequacy, training gaps, equipment design) drive multiple events

Change control assessment:

• Volume of changes by type (process, facility, equipment, material, method, specification)
• Change implementation cycle time from request to closure
• Post-change effectiveness verification results
• Unplanned changes (emergency or expedited) requiring retrospective validation
• Regulatory notification requirements and submission status

CAPA effectiveness:

• Open CAPA status and aging (overdue actions requiring escalation)
• CAPA recurrence rate (indicating ineffective root cause analysis)
• Verification of effectiveness (did the action prevent recurrence?)
• Preventive action identification from trending and risk assessment
• CAPA categorization by initiating source (deviation, audit, complaint, validation, PQR)

4. Supply Chain and Materials Quality

Raw material performance:

Supplier quality metrics:

• Supplier audit schedule compliance and critical findings
• Raw material testing failure rates by supplier
• Supplier CAPA responsiveness and closure timeliness
• Supplier change notification compliance
• Alternate supplier qualification status for business continuity

5. Post-Market Performance

Customer complaints and returns:

• Complaint rate per batch or per dosage units distributed
• Complaint categorization (product quality, packaging defect, labeling issue, stability concern)
• Confirmed vs unconfirmed product defects
• Field alert reports and regulatory notification requirements
• Correlation between complaints and manufacturing periods or sites

Adverse event correlation:

• Product quality complaints potentially related to adverse drug events
• Trending of quality-related pharmacovigilance signals
• Regulatory agency inquiries related to product quality
• Risk assessment of quality attributes that could impact safety or efficacy

Step-by-Step PQR Implementation Process

Implementing an effective product quality review program requires systematic planning, cross-functional collaboration, and robust data management capabilities.

Step 1: Define Review Scope and Frequency

Determine products to include:

• All products manufactured at the site during review period (including clinical and validation batches)
• Products manufactured by contract organizations (CMOs) if the company holds marketing authorization
• Combination of products when shared process platforms allow meaningful comparison

Establish review frequency:

• Annual reviews: Minimum standard for established commercial products
• Semi-annual reviews: Newly launched products (first 2-3 years post-approval), products with recent quality issues, or high-complexity biologics
• Quarterly reviews: Products under regulatory scrutiny (consent decree, warning letter follow-up), products with narrow therapeutic index

Define review period:

• Calendar year (January-December) for alignment with business planning
• Anniversary of product approval for lifecycle alignment
• Rolling 12-month window updated quarterly for more timely trending

Step 2: Establish Data Collection Systems

Effective PQRs require automated data aggregation from multiple quality systems:

Source systems inventory:

Data warehouse approach:

Leading pharmaceutical companies implement dedicated quality data warehouses that:

• Consolidate data from disparate source systems into unified data models
• Enable pre-built PQR dashboards and automated report generation
• Provide statistical analysis tools (SPC charting, capability analysis, trend detection)
• Maintain historical PQR data for year-over-year comparison
• Support regulatory inspection readiness with rapid data retrieval

Step 3: Conduct Statistical Analysis

Raw data compilation does not constitute an effective PQR. Quality teams must apply statistical methods to identify meaningful trends and process changes:

Statistical process control (SPC) charting:

• X-bar and R charts for continuous variables (assay, dissolution, hardness)
• Individuals and moving range (I-MR) charts for low-volume products
• Attribute charts (p-chart, np-chart) for defect rates and compliance metrics
• Detection of out-of-control signals (runs, trends, points beyond limits)

Process capability analysis:

• Cp (process capability) calculation: (USL - LSL) / (6 × standard deviation)
• Cpk (process capability index accounting for centering): min[(USL - mean) / (3 × σ), (mean - LSL) / (3 × σ)]
• Target capability benchmarks: Cpk ≥ 1.33 for routine products, Cpk ≥ 1.67 for critical quality attributes
• Trending of capability indices over time to detect process drift

Comparative analysis:

• Year-over-year performance comparison to identify improving or degrading trends
• Site-to-site comparison for multi-site products to identify best practices or problems
• Product-to-product comparison within process platforms to leverage shared learning
• Before-after analysis for process changes, equipment upgrades, or material substitutions

Step 4: Identify Trends and Root Causes

The analytical phase should answer critical questions:

Process control assessment:

• Is the process operating within validated ranges?
• Have process parameters drifted toward specification limits?
• Do control charts show special cause variation requiring investigation?
• Are there seasonal or temporal patterns in quality performance?

Quality risk evaluation:

• Which quality attributes show increasing variability or adverse trends?
• Are there early indicators of potential future OOS events?
• Do customer complaints correlate with specific manufacturing periods or conditions?
• Are supplier changes or material variations affecting product quality?

Continuous improvement opportunities:

• Can specification ranges be tightened based on demonstrated capability?
• Should process parameters be adjusted to improve centering and reduce variability?
• Would additional in-process controls enhance quality assurance?
• Are there automation or technology opportunities to reduce human error?

Step 5: Document Conclusions and Actions

The PQR report must translate data analysis into clear conclusions and actionable recommendations:

Overall assessment statement:

Example: "The product quality review for Product ABC 50mg tablets covering January 1, 2025 through December 31, 2025 demonstrates that the manufacturing process remains in a state of control. All critical quality attributes met specifications, with process capability indices exceeding Cpk 1.33 targets. Three areas for continuous improvement have been identified and are addressed through CAPA actions detailed in Section 6."

Action categories:

CAPA linkage:

Each PQR action requiring corrective or preventive measures should:

• Generate a formal CAPA record in the quality management system
• Assign clear ownership (individual responsible, not department)
• Define success criteria (how will effectiveness be measured?)
• Establish completion timeline based on quality risk assessment
• Include verification plan (how will effectiveness be confirmed in subsequent PQR?)

Step 6: Management Review and Approval

Product quality reviews require documented senior management oversight:

Review and approval hierarchy:

1. QA Leadership - Reviews analytical rigor, regulatory compliance, action appropriateness
2. Manufacturing Leadership - Confirms manufacturing data accuracy, commits to process improvement actions
3. Quality Leadership (VP Quality or Chief Quality Officer) - Approves conclusions and authorizes resource allocation for identified actions
4. Senior Management - Reviews strategic quality trends, ensures quality system effectiveness

Management review meeting agenda:

• Executive summary of quality performance across all products under review
• Year-over-year trending and comparison to quality objectives
• Critical findings requiring immediate attention or investment
• Status of actions from prior review cycles
• Resource requirements for proposed improvement initiatives
• Regulatory inspection preparedness assessment

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Regulatory Expectation: EMA and FDA inspectors expect to see evidence that management reviews PQR findings and makes informed decisions. Simply signing a report is insufficient; meeting minutes or decision documentation should demonstrate active engagement.

Common PQR Deficiencies and Inspection Findings

Regulatory inspections frequently identify product quality review deficiencies. Understanding common findings helps quality teams proactively strengthen their PQR programs.

Deficiency Category 1: Incomplete Scope

Inspection findings:

• PQR failed to include all batches manufactured during review period (missing validation batches, clinical batches, or batches manufactured at CMOs)
• Review omitted required data elements (stability, complaints, changes, supplier performance)
• Analysis excluded specific manufacturing sites or strength presentations without justification
• Prior PQR CAPAs not tracked to closure and effectiveness verification

Corrective approach:

• Implement checklist of required PQR elements mapped to regulatory expectations (ICH Q10, EU GMP, FDA guidance)
• Establish data extraction queries that automatically include all relevant batches based on date range and product code
• Create PQR template sections for each required element with validation that sections cannot be omitted
• Maintain CAPA tracking dashboard showing PQR-initiated actions through closure

Deficiency Category 2: Inadequate Trending and Analysis

Inspection findings:

• Data presented as tables without statistical analysis or trend evaluation
• No control charts or capability analysis for critical quality attributes
• Failure to identify adverse trends that should have triggered investigation
• Year-over-year comparison missing, preventing detection of long-term drift
• No evaluation of process capability against specification limits

Corrective approach:

Deficiency Category 3: Lack of Management Oversight

Inspection findings:

• PQR reports prepared by QA but no evidence of management review or action
• Signature pages without meeting minutes or decision documentation
• Actions identified in PQR but not implemented (no follow-through)
• No evidence that senior leadership uses quality reviews for strategic planning
• Missing approval signatures or delayed approvals (reports completed many months after review period)

Corrective approach:

• Schedule management review meetings as part of PQR standard operating procedure
• Document management review outcomes (decisions, resource commitments, strategic initiatives)
• Establish PQR completion timeline with milestones (data collection by MM/DD, draft by MM/DD, management review by MM/DD, approval by MM/DD)
• Include PQR review in senior management meeting agendas (Board of Directors quality updates, executive committee reviews)
• Track PQR KPIs visible to leadership (on-time completion rate, action closure rate, trend improvement metrics)

Deficiency Category 4: Ineffective Actions

Inspection findings:

• Actions identified in previous PQR remain open or incomplete in subsequent review
• Recurrent issues indicating previous corrective actions were ineffective
• Actions are superficial (e.g., "retrain staff") without addressing systemic root causes
• No verification that implemented actions achieved intended improvement
• Missing preventive actions based on trending and risk assessment

Corrective approach:

• Apply rigorous root cause analysis methodologies (5-Why, Fishbone, Fault Tree Analysis) before defining actions
• Differentiate between corrective actions (addressing known problems) and preventive actions (addressing risks identified through trending)
• Establish effectiveness criteria at time of CAPA creation (e.g., "reduce deviation recurrence rate by 50% over next 6 months")
• Include effectiveness verification as standard element in subsequent PQR
• Escalate aging or ineffective CAPAs to senior management for resource allocation or strategy revision

Automating Product Quality Reviews

Manual PQR preparation is time-intensive, error-prone, and struggles to keep pace with modern pharmaceutical manufacturing complexity. Quality teams are increasingly adopting technology solutions to automate data aggregation, analysis, and reporting.

Challenges with Manual PQR Processes

Time requirements:

• Average PQR for a single product requires 40-80 hours of QA staff time for data collection, analysis, and reporting
• Multi-product sites conducting 10-20 annual PQRs can consume 500-1,600 QA hours annually
• Data extraction from multiple systems (LIMS, MES, QMS, stability) requires manual exports, spreadsheet manipulation, and error checking
• Statistical analysis in spreadsheets is manual, lacks validation, and prone to formula errors

Quality and compliance risks:

• Manual data transcription introduces errors in PQR reports
• Inconsistent analysis methodologies across products or review cycles
• Delayed PQR completion due to resource constraints
• Difficulty demonstrating data integrity and traceability to inspectors
• Version control challenges when multiple reviewers collaborate on reports

Technology Solutions for PQR Automation

Quality data warehouse platforms:

Leading pharmaceutical companies implement enterprise quality data warehouses that:

• Integrate data from LIMS, MES/EBR, QMS, stability systems, and complaint management via validated interfaces
• Apply pre-configured data transformations and calculations (e.g., Cpk calculations, control limits, trending algorithms)
• Maintain historical data for multi-year comparative analysis
• Provide audit trails showing data lineage from source systems through transformations to final PQR outputs
• Enable inspector access to underlying data during regulatory inspections

PQR-specific software tools:

Several specialized platforms focus specifically on product quality review automation:

AI-powered quality intelligence:

Emerging artificial intelligence and machine learning applications for product quality reviews include:

• Anomaly detection algorithms that identify unusual patterns in quality data that might be missed by traditional statistical methods
• Natural language processing to analyze deviation and investigation narratives, identifying common root causes and themes across incidents
• Predictive modeling that forecasts potential quality issues based on trending data, enabling proactive intervention
• Automated insight generation where AI systems suggest potential root causes or improvement opportunities based on patterns in multi-dimensional quality data

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Validation Consideration: Automated PQR systems must be validated per GxP requirements. Validation scope includes data extraction accuracy, calculation verification, report generation reliability, and audit trail functionality. Risk-based validation approaches can streamline implementation while ensuring compliance.

Best Practices for Effective Product Quality Reviews

Quality leaders at top pharmaceutical and biotech companies apply these proven practices to maximize PQR value:

1. Start Early in Product Lifecycle

Benefit: Establishing PQR processes during product development creates baseline quality performance data and identifies optimization opportunities before commercial scale-up.

Implementation:

• Conduct "mini-PQRs" after process performance qualification (PPQ) batches to assess manufacturing consistency
• Define PQR metrics and control limits based on validation data rather than waiting for commercial history
• Include clinical manufacturing batches in early reviews to identify process improvements before commercial launch
• Use pre-approval PQR data to refine control strategies and specification ranges

2. Integrate with Knowledge Management

Benefit: PQR findings contribute to the pharmaceutical development knowledge space, informing future product improvements and lifecycle management.

Implementation:

• Cross-reference PQR findings with product characterization studies and process development reports
• Update process understanding documentation (design space, control strategy) based on commercial manufacturing data
• Use PQR trends to inform post-approval change protocols and continuous verification strategies
• Share learnings across product platforms and development teams to avoid repeating issues

3. Align Review Cycles Across Products

Benefit: Synchronized PQR schedules enable portfolio-level quality assessment and resource planning.

Implementation:

• Stagger review completion dates to balance QA workload throughout the year
• Group products by platform or manufacturing area for comparative analysis
• Align PQR timing with management quality review meetings for timely decision-making
• Coordinate with other quality activities (annual management review, self-inspection, regulatory reporting) to avoid duplication

4. Focus on Actionable Insights

Benefit: PQRs that drive concrete improvements provide greater business value than those serving only compliance documentation purposes.

Implementation:

5. Leverage Cross-Functional Expertise

Benefit: PQR preparation and review benefit from diverse perspectives beyond QA.

Implementation:

• Involve manufacturing in process performance interpretation and improvement ideation
• Engage analytical development for method capability assessment and OOS investigation insights
• Include regulatory affairs for assessment of findings requiring regulatory notification
• Consult engineering for equipment performance analysis and capital improvement prioritization
• Partner with commercial teams to correlate quality trends with market complaints or competitive intelligence

6. Benchmark Against Industry Standards

Benefit: External perspective helps identify whether quality performance is acceptable or requires improvement.

Implementation:

• Compare deviation rates, OOS frequencies, and complaint rates to industry benchmarks when available
• Participate in industry working groups (ISPE, PDA) that share anonymized quality performance data
• Reference published quality metrics from major pharmaceutical companies in annual reports or conference presentations
• Engage consultants or contract organizations that provide multi-client comparative data (anonymized)

Quality Review Report Template

An effective product quality review report structure ensures consistency, completeness, and regulatory compliance:

Template Sections

1. Title Page and Approval Signatures

• Document title: "Product Quality Review - [Product Name] [Review Period]"
• Document number and version control
• Approval signature blocks: QA, Manufacturing, Quality Leadership, Senior Management
• Date of approval

2. Executive Summary (1-2 pages)

• Review period and scope (products, sites, batch count)
• Overall quality assessment conclusion
• Key performance highlights (metrics that exceeded targets)
• Critical findings requiring management attention
• Action summary (number of CAPAs initiated, high-priority items)

3. Product Overview

• Product description (dosage form, strengths, presentation)
• Manufacturing site(s) and process overview
• Regulatory status (marketing authorizations, regulatory commitments)
• Production volume statistics (batches manufactured, units produced)
• Significant changes during review period

4. Manufacturing Performance

• Batch production summary table
• Process parameter trending with control charts
• Manufacturing yield analysis
• Equipment performance metrics
• Environmental monitoring trending
• Rejected batch analysis

5. Product Quality Analysis

• Release testing trending by quality attribute
• Specification compliance rates
• Process capability analysis (Cp, Cpk)
• OOS investigation summary
• Comparative analysis (year-over-year, site-to-site)

6. Stability Program Review

• Ongoing stability results vs. specifications
• Accelerated stability trends
• Stability protocol compliance (sample pulls, testing timelines)
• Shelf-life assessment and retest dating
• Stability-related OOS events

7. Quality System Performance

• Deviation trending and analysis
• Change control summary
• CAPA status and effectiveness
• Supplier quality performance
• Training compliance for product-specific procedures

8. Post-Market Performance

• Customer complaint summary and trending
• Product return analysis
• Field alert reports and regulatory inquiries
• Adverse event correlation assessment

9. Prior PQR Action Closure

• Status of actions from previous review cycle
• Effectiveness verification for completed actions
• Carryover items requiring continued attention

10. Conclusions

• State of control assessment
• Comparison to product quality objectives
• Regulatory compliance status
• Overall quality performance rating

11. Actions and Continuous Improvement

• Table of identified actions with:

- Finding description

- Assigned CAPA number

- Action owner and target completion date

- Priority/risk categorization

• Preventive action opportunities
• Regulatory notification requirements

12. Appendices

• Detailed statistical analysis and charts
• Investigation summaries for significant events
• Supplier audit reports
• Regulatory correspondence
• Supporting documentation references

Key Takeaways

Next Steps

Understanding product quality review requirements is the first step. The next challenge is efficiently aggregating multi-system data, conducting rigorous statistical analysis, and completing reviews on schedule while maintaining full-time quality operations.

Organizations managing regulatory submissions benefit from automated validation tools that catch errors before gateway rejection. Assyro's AI-powered platform validates eCTD submissions against FDA, EMA, and Health Canada requirements, providing detailed error reports and remediation guidance before submission.

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