Annual Product Quality Review (APQR) Software

Every commercial product manufactured in the Pharmaceutical, Biotech, and Bio-sciences Industries undergo a Product Quality Review (PQR). This requirement is published as the final current good manufacturing practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). The PQR has largely been termed ‘Product Annual Review’ or the ‘Annual Product Review’ (APQR) by FDA and within the pharmaceutical industry. The products follow the established protocols of the US FDA with GMP standards, and they are distributed within the United States markets.

The Annual Product Quality Review (APQR) was introduced as part of the GMP practices to provide manufacturers of pharmaceutical products with a set of reliable procedures. These procedures must be followed in reviewing the quality standards of every drug product. The content and management of Quality Product Reviews are to be established according to the regulatory requirements.

The annual product quality review within pharmaceutical companies is therefore necessary for the verification of the consistency of the manufacturing procedures, examination of trends, identification of changes required in the specifications or the methods or production technique.

The guideline established in ICH Q7 2.5 Product Quality Review 2.50 states that regular quality reviews of APIs should be conducted to verify the consistency of the process. This is referred to by EU guidelines for Good Manufacturing Practice as PQR (Product Quality Review), and the processes adopted for Product Quality Review (PQR) are based on EU GMP standards.

Developed on LOW CODE PLATFORM,  AmpleLogic APQR Software captures information manually and collects information from other sources. It extracts this information by combining it with software systems that the company may utilize. LMS, QMS, BMS, and MES/eBMR are examples of these software systems. The program may also collect data from a range of different software systems and legacy products in your organization’s IT infrastructure.

Key data captured in AmpleLogic Product Quality Review Software

  • The Annual Product Review (APR) software collects batch information such as product code, shelf life, date of production, and date of expiration, as well as pack size. Information on process yields such as granulation, compression, coating and packaging are also captured.
  • Other information like raw material, packaging materials, batch failure or batch Rejections, deviations,  are captured.
  • It provides information on process control and analytical test results
  • 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.
  • Categorized month-wise and condition-wise details relating to the product stability
  • Provision to capture both child & parent products in the generated APQR document .
  • 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
  • Provision to convert the cpk values from 6 sigma to 3 sigma in case of any deviations
  • Provides information on product quality agreement for the respective API along with details of raw materials and their suppliers.
  • Continuous process verification can be done through out the APQR system by using six pack report and Nelson’s rule to investigate about each and every batch data. 
  • It provides an Analytical Method Validation and revalidation of 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) at any time based on the period of selection.
  • Provision of auto alerts for delays beyond seven days.
  • The software manages the master data for all parameters along with limits like NLT and NMT.
  • It provides statistical analysis and trends on Assay, Water Content, PH, Specific Impurities, and Total Impurities.
  • It creates reports on batch-wise trends to track granulation yield, compression yield along with coating and packing yield.
  • The system can generate a six-pack report with performance indices of 3 Sigma or 6 Sigma.
  • The APR software program provides an organization with easy access to dashboards that provide intelligence regarding trends of each in-process parameter. Information is also captured along with a lower and upper limit.
  • Users can auto version the PQR document.
  • The software provides trends related to Analytical Parameters and Stability Trends.
  • Validation color will be indicated in the PQR System if any out of limit entered by the user.
  • It auto-calculates the Mean, Median, and Standard Deviations.
  • There is also 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) and Standard Deviations by using the R-Tools and R-Studio.
  • The Software will allow the generation of the quality review for any period. It can also generate a comparison between two different periods.
  • This system can generate various trend reports of yield, critical process parameter, In-process quality parameter, and other required reports.
  • By integrating with R-tools and R-Studio, APQR System will be able to generate the control charts I Chart, Normal Probability Plot, Moving range chart, Process Capability Analysis and last 15 observations will be shown, where variation of a parameter across different batches can be seen.
  • The system complies with all major standards including 21 CFR PART 11, MHRA, and EU Annex 11 Standards.

AmpleLogic Product Quality Review Software conforms with electronic record standards set by the TGA, CDSCO, HEALTH CANADA, the MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, among other regulatory agencies


Other industries that can take advantage of APQR Software

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages

Kindly contact us for more information about how your organization can benefit from AmpleLogic APQR Software.