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)
Get PQR reports anytime based on predefined templates
Provides auto alerts for delays beyond seven days, ensuring timely actions
Gathering comprehensive data across departments (manufacturing, quality control, etc.) is complex and time-consuming, especially in large operations with legacy systems.
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.
Compliance with evolving regulatory guidelines (e.g., EU GMP, FDA) requires constant updates to the PQR process, demanding adaptability and up-to-date expertise.
Limited advanced analytical tools in Product Quality Review (PQR) can hinder data accuracy, trend analysis, and timely identification of process inconsistencies.
Effective PQR requires cooperation across departments, which can be challenging if there are communication gaps or resistance to information sharing.
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.
Generate three and six-pack reports instantly for regulatory submissions
Maintain Critical Process Parameters and Critical Quality Attributes
Maintain Critical Process Parameters and Critical Quality Attributes
In-depth process analysis using indices such as Cp, CPK, CPU, CPL
Generate quality review reports anytime based period of selection
Generate six-pack report using performance indices of 3 Sigma and 6 Sigma
Manages master data for all parameters along with limits like NLT,NMT, Min & Max, Descriptive, Equal to, Report Value
Integrates perfectly with all LMS, QMS, BMS, and MES/eBMR systems for holistic data capture
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
Generate reports on batch-wise trends to track granulation yield, compression yield along with coating and packing yield
Supports “Golden Batch” by identifying and replicating optimal manufacturing conditions consistently
Continuous monitoring of critical parameters throughout the manufacturing process for compliance and quality assurance
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
Track critical quality attributes (CQAs) and critical process parameters (CPPs) using control charts
Identifies Out-of-Specification (OOS) and Out-of-Trend (OOT) by systematically analyzing production and quality control data
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
Ensure the accuracy of analytical methods with automated calculation of Mean, Median, and Standard Deviations
Amplelogic APQR or PQR template can be customized to align with various market requirements or different SOPs (Standard Operating Procedures)
Integrates comprehensive analytical functionalities, eliminating the need for external tools like SAS, MiniTab, or SPSS, ensuring a seamless and efficient APQR experience
The software has the capability to extract manual BMR template data using OCR technology, which can then be imported into the APQR application
Automate the data collection process, reducing manual errors and streamlining the analysis of vast datasets
Automatically version PQR documents, maintaining accurate records for compliance
Helps departments collaborate and enhances communication for streamlining processes
Provides auto alerts for delays beyond seven days and warnings for out-of-specification scenarios and deviations
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 streamlines assessments, ensuring compliance and efficiency while reducing manual errors and saving valuable time
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
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
Generate graphical comparison of process parameters to assess the impact of CAPA implementation, vendor changes, or other quality management initiatives
Supports proactive quality assurance with CPV and Real-Time Release Testing (RTRT) in APQR, shifting from traditional batch testing
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
Industry-Specific Software for Enhanced Quality and Compliance
Maintaining cleanliness and hygiene in pharmaceutical manufacturing is crucial for ensuring product safety and quality, with patient well-being as the top priority. Cleaning validation plays
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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