TRUCHEMY APQR
Annual Product Quality Review System (PQR/APQR)
Innovative AI-Enhanced Framework for Quality & Compliance.
Uses AI to streamline quality processes, predict risks, and enhance compliance—enabling smarter, faster decision-making across pharmaceutical operations.
Stay Audit-Ready with Truchemy’s AI-Powered APQR
Inadequate PQR reporting has led to audit failures for 7 out of 10 pharmaceutical companies. The lack of seamless integration between solutions poses significant challenges, making it difficult for the pharmaceutical industry to generate instant, globally compliant PQR audit reports. This impacts both product quality and organizational credibility.
Truchemy’s cutting-edge AI-driven APQR software is here to transform the process. It enables precise creation of Product Quality Review (PQR) and CPV reports for audits and regulatory submissions, adhering to the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e)). Incorporating OCR data extraction and AI chatbot capabilities, Truchemy’s APQR solution accelerates document processing, ensures quick access to vital information, and enhances audit readiness alongside operational productivity.
Unwavering Focus on AI-Backed Quality
On-Demand Report Generation
Access PQR reports instantly using predefined templates.
Ready for Audits
Achieve audit readiness with precise PQR and CPV report generation.
Ongoing Process Monitoring
Track and monitor key parameters continuously throughout the production process.
AI Chatbot & OCR Data Extraction
Leverage OCR for extracting data from physical documents and retrieve any information via an AI-powered chatbot.
PQR Compliance Difficulties
Integration
Gathering and unifying data from departments like manufacturing and quality control is complex and time-consuming, especially in large operations dependent on legacy systems.
Ensuring Data Accuracy
Guaranteeing data integrity—through accurate and consistent entry—is essential to avoiding errors that could compromise product quality and regulatory adherence in manufacturing.
Regulatory Compliance
Keeping up with shifting regulatory standards—such as EU GMP and FDA guidelines—necessitates continuous updates to the PQR process, requiring flexibility and current industry expertise.
Limited PQR Analytics
The absence of sophisticated analytical tools in Product Quality Review (PQR) can impede data precision, trend evaluation, and prompt detection of process irregularities.
Interdepartmental Coordination
Successful PQR implementation depends on seamless collaboration across teams, but challenges arise when communication barriers or reluctance to share data hinder efficiency.
Drive Process Innovation with Truchemy APQR
Instant PQR Report Generation
Generate GMP-compliant Product Quality Review (PQR) reports anytime based on the selected period.
Six-Pack Report Generation
Create six-pack reports utilizing 3 Sigma and 6 Sigma performance indices for process evaluation.
Master Data Management
Effectively handle master data, including parameter limits such as NLT, NMT, Min & Max, Descriptive, Equal to, and Report Value.
Seamless System Integration
Achieve smooth connectivity with LMS, QMS, DMS, and MES/eBMR systems for comprehensive data consolidation.
OCR Data Extraction
Transform physical documents into digital formats for accurate data retrieval, enhancing compliance and audit readiness.
AI-Powered Chatbot
AssistanceRetrieve essential data from reports and integrated systems via an AI chatbot, ensuring efficient internal and external audits.
Advanced Statistical and Trend Analysis
Analyze critical parameters related to stability, yield, in-process quality, and other essential factors with statistical insights.
Batch Trend Evaluation
Generate reports to monitor trends in granulation yield, compression yield, coating, and packaging processes.
Golden Batch Optimization
Support “Golden Batch” replication to maintain optimal manufacturing conditions consistently.
Continuous Process Verification (CPV)
Ensure ongoing monitoring of crucial manufacturing parameters for compliance and quality assurance.
Process Enhancement with Data Analytics
Automatically calculate Cp, CPK, CPU, CPL, UCL, LCL, and Standard Deviations using R-Tools and R-Studio for deep process optimization.
Tracking CPPs & CQAs
Monitor critical quality attributes (CQAs) and critical process parameters (CPPs) using control charts.
OOT & OOS Detection
Identify Out-of-Trend (OOT) and Out-of-Specification (OOS) instances through systematic production and quality data analysis.
Comprehensive Control Chart Generation
Create control charts—including I Charts, Normal Probability Plots, Moving Range Charts, and Process Capability Analyses—to evaluate parameter variations across batches.
Analytical Method Validation
Validate analytical methods with automated Mean, Median, and Standard Deviation calculations.
Customizable PQR Templates
Tailor APQR/PQR templates to meet market-specific needs and Standard Operating Procedures (SOPs).
Integrated Analytical Capabilities
Streamline APQR processes by eliminating reliance on external analytical tools like SAS, MiniTab, or SPSS.
Manual BMR Data Extraction via OCR
Extract manual BMR template data using OCR technology and seamlessly import it into the APQR system.
Automated Data Collection & Analysis
Reduce manual errors and optimize large dataset analysis with automated data processing.
PQR Auto-Versioning
Automatically manage document versions to ensure compliance and record accuracy.
Cross-Department Collaboration
Enhance interdepartmental communication for improved process efficiency.
Automated Alerts & Notifications
Receive alerts for delays exceeding seven days and warnings for specification deviations.
Centralized Monitoring of Critical Control Points (CCP)
Define CCP tolerances and escalate deviations beyond Proven Acceptable Range (PAR) or Normal Operating Range (NOR).
Automated Quality Review Processes
Improve compliance and efficiency with automated PQR assessments while reducing manual workloads.
Nelson’s Rule-Based Monitoring
Implement Nelson’s Rule for pharma process monitoring and effective CPV report generation, detecting “Out of control” scenarios.
CPK Assessment System
Receive color-coded notifications for process capability ratings.
Comparative Process Parameter Reporting
Generate graphical comparisons of process parameters to assess the impact of CAPA implementation, vendor modifications, and other quality initiatives.
Real-Time Release Testing (RTRT)
Ensure proactive quality assurance by integrating CPV with RTRT, moving beyond traditional batch testing.
Robust Regulatory Compliance
Built-in compliance mechanisms include e-signatures and audit trails per 21 CFR Part 11, MHRA, and EU Annex 11. Fully adheres to regulatory standards across major agencies worldwide, including TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.
Why Choose Truchemy APQR?
Truchemy’s AI-powered APQR solution is built to serve Pharmaceuticals, API Manufacturers, CDMOs, Biotech, Biosciences, and CROs. Designed in compliance with US FDA and GMP standards, it aligns with ICH Q7 2.5, ensuring regular quality reviews of APIs, known as Product Quality Reviews (PQRs) under EU GMP guidelines.
With Truchemy, PQR report generation is simplified through advanced statistical modeling, trend analysis, and performance indices, allowing for more informed decision-making. Strengthen compliance efforts and product quality consistency with integrated CCP monitoring and excursion escalation beyond Proven Acceptable Range (PAR) and Normal Operating Range (NOR). Generate three and six sigma reports for regulatory submissions, receive instant alerts, and integrate the system seamlessly to uphold EU GMP and FDA regulatory standards.
Adherence
Maintain adherence to 21 CFR PART 11, MHRA, EU Annex 11, and other global standards.
CPP & CQA Oversight
Track CPPs and CQAs continuously to strengthen process control.
Reporting
Instantly create three and six-pack reports to streamline regulatory submissions.
Benchmarking
Analyze processes comprehensively using Cp, CPK, CPU, and CPL indices.