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

Continued Process Verification (CPV)

Continuous monitoring of critical parameters throughout the manufacturing process

Comprehensive Integration

Integrates with LMS, QMS, BMS, and MES/eBMR for holistic data capture

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

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Ace Continuous Process Improvement with AmpleLogic APQR

Instant PQR Report Generation

AmpleLogic's GMP Product Quality Review Software generates 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

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Bharat Serums leverages AmpleLogic’s APQR to streamline compliance and enhance regulatory readiness.

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Frequently Asked Questions

AmpleLogic APQR is designed to streamline the Annual Product Quality Review process, ensuring compliance, and providing detailed insights into product quality trends.

The software triggers immediate alerts for deviations, allowing timely corrective actions to maintain product quality.

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.

Yes, AmpleLogic APQR seamlessly integrates with various systems, including LMS, QMS, BMS, LIMS, Stability, SAP(ERP), DMS and MES/eBMR for comprehensive data capture.

The software conducts statistical analysis on multiple parameters to generate trend charts, control charts, process capability index reports, and Nelson’s rules reports.

Yes, AmpleLogic APQR complies with major standards including 21 CFR PART 11, MHRA, EU Annex 11, etc ensuring regulatory adherence.

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.

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.

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.

 

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