APQR

APR Software for Pharmaceutical Biotech and Biosimilar Industry

Annual Product Quality Review (APQR) will be conducted for each commercial product manufactured in the Pharmaceutical, Biotech and Bio-similar Industry. The aim of this annual product review within the pharmaceutical companies is to verify the consistency of the process, to assess trend, to determine the need for the changes in the specifications, production, manufacturing, Standard operating procedures(SOP) and also to evaluate the need for re-validation.

Annual Product Quality Review (APQR) in pharmaceutical and biotech companies are important for communication between manufacturing, quality, and regulatory affairs, to enable quality improvement process. Content and management of Annual Product Reviews should be established according to the regulatory requirements.

Annual Product Review (APR) is the terminology used for the products delivered to the US Market and comply with US FDA guidelines by following the GMP Standards. This APQR software must comply with 21 CFR Part 11 guidelines.

In EUROPE the same concept will be referred to as “Product Quality Review”. the procedure followed in Product Quality Review (PQR) is based on EU GMP guidelines and the software that delivers APQR must comply with EU Annex 11 Guidelines.

AmpleLogic APQR Software Captures the information manually and also extract the data by integrating with Other software systems namely LMS, QMS, BMS (Building Management Systems), MES/ eBMR and historian databases which are connected with equipment.

The Key information captured in APR Software is

  • Batch details that include Product Code, Shelf life, Manufacturing, and Expiry dates. Pack Size and Process wise Yield details like Granulation, Compression, Coating, and Packing.
  • Raw material, packaging materials
  • Process control and Analytical test results
  • Batch failure or Batch Rejections
  • Deviations
  • In Process Parameters for Granulation, Compression, Coating and Packing Processes
  • Out of specification and out of trend results
  • Process change requests and also Analytical Change Requests
  • Marketing authorization and Marketing variations namely label changes
  • Product Stability information month and condition wise
  • Product returns, Market complaints, Product recalls
  • Field alerts
  • Product Related CAPA’s
  • Marketing commitments
  • Equipment and utilities utilized during the making of the Product and their Qualification Status e.g HVAC, Water, Compressed Gas, etc..
  • Details from building management systems namely temperature and humidity records
  • Product Technical agreement for API, raw materials with Supplier/s
  • Product Quality agreement for API, raw materials with Supplier/s
  • Packaging material manufacturer Details and Specifications
  • Analytical Method Validation and revalidation data
  • Microbiological method Validation and revalidation data

The APQR/APR software helps in

  • Auto generates APQR word document for every product manufactured as per the predefined template based on the selection of the start and end date.
  • Auto Alerts just in case of delays beyond 60 days
  • AmpleLogic PQR software manages all the Parameters master data along with limits like NLT and NMT.
  • Generating Trends Batch wise on Granulation Yield, Compression Yield, Coating Yield, and Packing Yield.
  • APR solution helps to create dashboards for trends of each in-process parameter captures in each or every process along with a Lower limit and Upper limit
  • Trends of Analytical Parameters.
  • Stability Trends.
  • Auto calculation of Mean, Median and Standard Deviations.
  • Auto Generation of CPK (Process Capability Index).
  • Auto-versioning of PQR Document.
  • Comparison between current to Previous Year Data

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