AmpleLogic APQR
Annual Product Quality Review System
Steep Quality Assurance, Maintain Regulatory Compliance
Generate PQR Reports Instantly!
AmpleLogic PQR software revolutionizes product quality review for Pharmaceutical, API (Active Pharmaceutical Ingredient) Manufacturers, Contract Development and Manufacturing Organization (CDMO), Biotech, Biosciences and Contract Research Organization (CRO) Industries. Generate Annual Product Quality Review (PQR) reports and CPV reports anytime as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). AmpleLogic APQR software follows established protocols of US FDA and GMP standards. ICH Q7 2.5 proposes regular quality reviews of APIs, which are referred to as Product Quality Reviews (PQRs) in EU guidelines for Good Manufacturing Practice (GMP)
Generate Reports Anytime
Get PQR reports anytime based on predefined templates
Real-time Alerts
Provides auto alerts for delays beyond seven days, ensuring timely actions
Challenges in Pharma Product Quality Review (PQR) Process
Data Collection and Integration
Gathering comprehensive data across departments (manufacturing, quality control, etc.) is complex and time-consuming, especially in large operations with legacy systems.
Data Accuracy and Consistency
Ensuring data integrity, including correct and consistent data entry, is critical to prevent errors that can impact product quality and regulatory compliance in manufacturing process.
Regulatory Compliance
Compliance with evolving regulatory guidelines (e.g., EU GMP, FDA) requires constant updates to the PQR process, demanding adaptability and up-to-date expertise.
Lack of PQR Analytical Systems
Limited advanced analytical tools in Product Quality Review (PQR) can hinder data accuracy, trend analysis, and timely identification of process inconsistencies.
Cross-functional Collaboration
Effective PQR requires cooperation across departments, which can be challenging if there are communication gaps or resistance to information sharing.
Why Choose AmpleLogic APQR?
Streamline PQR report generation with AmpleLogic. The software’s insightful statistical representation, trend analysis and performance indices aid in informed decision-making. Enhance compliance and ensure consistent product quality with CCP monitoring and excursion escalation beyond Proven Acceptable Range (PAR) and outside Normal Operating Range (NOR). Get detailed three and six sigma reports for regulatory submissions with enhanced real-time alerts. Seamlessly integrated into your operations, APQR adheres to the mandated regulatory standards such as EU GMP, FDA, etc.
Three & Six-Pack Report
Generate three and six-pack reports instantly for regulatory submissions
Regulatory Compliance
Adhere to 21 CFR PART 11, MHRA, EU Annex 11, etc
CPP & CQA Monitoring
Maintain Critical Process Parameters and Critical Quality Attributes
Process Capability Analysis
In-depth process analysis using indices such as Cp, CPK, CPU, CPL
Ace Continuous Process Improvement with AmpleLogic APQR
Instant PQR Report Generation
Generate quality review reports anytime based period of selection
Generate Six-Pack Report
Generate six-pack report using performance indices of 3 Sigma and 6 Sigma
Manage Master Data
Manages master data for all parameters along with limits like NLT,NMT, Min & Max, Descriptive, Equal to, Report Value
Seamless Integration
Integrates perfectly with all LMS, QMS, BMS, and MES/eBMR systems for holistic data capture
Statistical and Trend Analysis
Provides statistical analysis and trends on all the specified parameters related to analytical, stability, yield, critical process parameter, in-process quality parameter, and other required into the report
Batch-wise Trend Report
Generate reports on batch-wise trends to track granulation yield, compression yield along with coating and packing yield
Golden Batch Facilitation
Supports “Golden Batch” by identifying and replicating optimal manufacturing conditions consistently
Continued Process Verification (CPV)
Continuous monitoring of critical parameters throughout the manufacturing process for compliance and quality assurance
Process Improvement
Auto generates Process Capability (Cp), CPK (Process Capability Index), Process capability Upper limit (CPU), Process capability Lower Limit (CPL), Upper Control Limit (UCL), Lower Control Limit (LCL) and Standard Deviations by using R-Tools and R-Studio for in-depth process analysis and improvement
Determine CPP & CQA
Track critical quality attributes (CQAs) and critical process parameters (CPPs) using control charts
Identify OOT, OOS
Identifies Out-of-Specification (OOS) and Out-of-Trend (OOT) by systematically analyzing production and quality control data
Control Charts
Generates control charts - I Chart, Normal Probability Plot, Moving Range chart and Process Capability Analysis. Last 15 observations are shown to determine the variation of a parameter across different batches
Analytical Method Validation
Ensure the accuracy of analytical methods with automated calculation of Mean, Median, and Standard Deviations
Annual Product Quality Review Template
Amplelogic APQR or PQR template can be customized to align with various market requirements or different SOPs (Standard Operating Procedures)
Integrated Analytical Functionality
Integrates comprehensive analytical functionalities, eliminating the need for external tools like SAS, MiniTab, or SPSS, ensuring a seamless and efficient APQR experience
Manual BMR Data Extraction and Import via OCR
The software has the capability to extract manual BMR template data using OCR technology, which can then be imported into the APQR application
Automated Data Collection and Analysis
Automate the data collection process, reducing manual errors and streamlining the analysis of vast datasets
Auto Versioning
Automatically version PQR documents, maintaining accurate records for compliance
Cross-Functional Department Collaboration
Helps departments collaborate and enhances communication for streamlining processes
Auto-Alerts & Warnings
Provides auto alerts for delays beyond seven days and warnings for out-of-specification scenarios and deviations
Centralized Monitoring of Critical Control Points (CCP)
Establish tolerance for Critical Control Points (CCP) and escalate any excursions beyond Proven Acceptable Range (PAR) or outside Normal Operating Range (NOR)
Automated Product Quality Review
Automated product quality review streamlines assessments, ensuring compliance and efficiency while reducing manual errors and saving valuable time
Utilizes Nelson’s Rule
Uses Nelson’s Rule for proper monitoring of pharma processes and for generating effective CPV reports. It helps in detecting “Out of control” or Non-random conditions
Provides CPK Assessment
Colour coded CPK assessment notification. When CPK < 1, users are notified for process is unsatisfactory, when 1< CPK >= 1.33 users are notified for process is satisfactory and when CPK > 1.33 users are notified for process is highly satisfactory
Process Parameter Comparison Report
Generate graphical comparison of process parameters to assess the impact of CAPA implementation, vendor changes, or other quality management initiatives
Real-Time Release Testing (RTRT)
Supports proactive quality assurance with CPV and Real-Time Release Testing (RTRT) in APQR, shifting from traditional batch testing
Regulatory Compliance
Built-in compliance features like e-signatures, audit trials as required by 21 CFR Part 11, MHRA and EU Annexure 11. Complies with electronic record standards set by TGA, CDSCO, HEALTH CANADA, the MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, among other regulatory agencies
Bharat Serums leverages AmpleLogic’s APQR to streamline compliance and enhance regulatory readiness – Explore the full case study.
Industries We Serve
Industry-Specific Software for Enhanced Quality and Compliance
Frequently Asked Questions
What is the primary purpose of AmpleLogic APQR?
AmpleLogic APQR is designed to streamline the Annual Product Quality Review process, ensuring compliance, and providing detailed insights into product quality trends.
How does the software handle deviations?
The software triggers immediate alerts for deviations, allowing timely corrective actions to maintain product quality.
Does AmpleLogic offer SaaS PQR or APQR software?
Yes, AmpleLogic offers SaaS (Software as a Service) APQR software specifically designed for the pharmaceutical industry. Our SaaS solution provides a flexible, subscription-based model with automatic updates, ensuring you have access to the latest features and compliance tools at all times. Accessible from anywhere, our software integrates seamlessly with your existing systems, helping you manage product quality reviews efficiently and reduce manual efforts.
Can AmpleLogic APQR integrate with existing systems?
Yes, AmpleLogic APQR seamlessly integrates with various systems, including LMS, QMS, BMS, LIMS, Stability, SAP(ERP), DMS and MES/eBMR for comprehensive data capture.
What statistical analysis does the software perform?
The software conducts statistical analysis on multiple parameters to generate trend charts, control charts, process capability index reports, and Nelson’s rules reports.
Is AmpleLogic APQR compliant with industry standards?
Yes, AmpleLogic APQR complies with major standards including 21 CFR PART 11, MHRA, EU Annex 11, etc ensuring regulatory adherence.
What is Annual Product Quality Review in Pharma?
The Annual Product Quality Review (APQR) in pharma is a yearly assessment of a product’s quality. It involves reviewing data from manufacturing, quality control, and any issues that arose during the year. The goal is to ensure the product meets quality standards, identify trends, and make improvements, helping to maintain product integrity and comply with regulations.
What is GMP Product Quality Review?
Pharmaceutical product quality is evaluated systematically in compliance with Good Manufacturing Practices (GMP) through the Product Quality Review (PQR). It involves checking production and quality control information, like records of how products were made, test results, and any problems or complaints that came up. The PQR is used to make sure that products continuously fulfill quality standards, pinpoint areas that need improvement, and guarantee that regulations are followed. This review aids in preserving the general quality, effectiveness, and safety of the product throughout the manufacturing process.
Do you offer cloud-based APQR software?
Yes, we offer cloud-based APQR software tailored for the pharmaceutical industry. It enables seamless management of Annual Product Quality Reviews from anywhere, featuring automated report generation, regulatory compliance tools, and secure data storage for enhanced collaboration and accessibility.
Your Pharma Automation Starts Here
We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:
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