Annual Product Quality Review (APQR) Software
Product Quality Review (PQR)is conducted for each commercial product manufactured in the Pharmaceutical, Biotech and Bio-similar Industries. This requirement was published as final current good manufacturing practices (CGMP) regulations for drug products (21 CFR 211.180(e)), 21 CFR 211.180(e). It has been commonly referred to—by FDA and the pharmaceutical industry—as the “Product Annual Review” (PAR) or the “Annual Product Review” (APQR). The products are delivered to markets within the United States and they are in compliance with the guidelines laid down by the US FDA in accordance with GMP standards
The aim of this annual product quality review within the pharmaceutical companies is to verify the consistency of the manufacturing procedures, to examine trends, and to identify changes required in the specifications, or in the methods or technique for production. It also evaluates the Standard Operating Procedures and assesses the need for re-validation.
As per the guideline defined in ICH Q7 2.5 Product Quality Review 2.50, Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of the process.
Annual Product Quality Review (APQR), It was introduced as part of the GMP practices to provide manufacturers of pharmaceutical products with a set of reliable procedures that must be followed for reviewing the quality standards of every drug product. The content and management of Quality Product Reviews should be established according to the regulatory requirements.
EU Guidelines for Good Manufacturing Practice will refer to this as PQR (Product Quality Review), the procedure followed in Product Quality Review (PQR) is based on EU GMP guidelines
AmpleLogic APQR Software is developed on LOW CODE PLATFORM, Captures the information manually and extracts data from other sources by integrating with software systems which may be used by the company. These software systems include LMS, QMS, BMS and MES/eBMR. The software is also capable of capturing data from a variety of other software systems and legacy products which are a part of your organization’s IT environment.
Key data captured in AmpleLogic Product Quality Review Software
- Information about the batches which include product code, shelf life, date of manufacture and date of expiry along with size of the pack. The APQR software also captures information about process wise yield like granulation, compression, coating, and packing.
- Raw material, and packaging materials
- Process control and Analytical test results
- Batch failure or Batch Rejections
- In Process Parameters for Granulation, Compression, Coating and Packing Processes
- Out of specification and out of trend results
- Process change requests and other types of change requests like Analytical change requests
- Information related to marketing authorization and details of market variations like changes in the label.
- Details related to product stability categorized month wise and condition wise.
- Product returns, Market complaints, Product recalls
- Field alerts
- Product Related CAPA’s
- Marketing commitments
- Information about the equipment, instruments and utilities involved in the manufacture of the product including their qualification status. These include HVAC, water, and compressed gas.
- Details from Building Management Systems namely temperature and humidity records
- Product Technical agreement for API, raw materials with Supplier/s
- Information on Product Quality agreement for the respective API along with details of raw materials and their suppliers.
- Details and Specifications of the manufacture of packaging materials.
- Analytical Method Validation and re-validation data
Key Features of APQR and PQR Software
- AmpleLogic APQR Software auto generates APQR word document for every product manufactured as per the predefined template based on the selection of the start and end date.
- Teams can generate the Product Quality Review (PQR) any time based on the period of selection.
- Auto Alerts in case of delays beyond 7 days
- AmpleLogic PQR Software manages the master data for all parameters along with limits like NLT and NMT.
- Statistical Analysis and Trends on Assay, Water Content and PH, Specific Impurities and Total Impurities.
- AmpleLogic APQR Solution creates reports on batch wise trends to track granulation yield, compression yield along with coating and packing yield.
- AmpleLogic APQR Software system has capability to generate six-pack report with capability and performance indices with 3 Sigma or 6 Sigma.
- The APR software program provides organization with easy access to dashboards that provide intelligence regarding trends of each in-process parameter. Information is captured along with a lower and upper limit.
- The PQR software allows users to auto version the PQR document.
- Trends related to Analytical Parameters and Stability Trends.
- AmpleLogic APQR Solution auto calculates the Mean, Median and Standard Deviations.
- Auto Generation of 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).
- AmpleLogic PQR Software will allow to generate quality review for any period, can also generate the comparison between two different periods.
- This system has ability to generate various trend reports of yield, critical process parameter, In-process quality parameter and other required reports.
- In compliance with all major standards including 21 CFR PART 11, MHRA and EU Annex 11 Standards.
AmpleLogic Product Quality Review Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH
Other industries that can take advantage of APQR Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages