Annual Product Quality Review (APQR) will be conducted for each commercial product manufactured in the Pharmaceutical, Biotech and Bio-similar Industries. 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.
Infotronicx Pharmasol APQR Software Captures the information manually and also extract the data by integrating with other software systems namely PLMS, QMS, BMS (Building Management Systems), MES/ eBMR and historian databases which are connected with equipment.
The Key information is captured in APR Software :
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
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
Product Related CAPA’s
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 re-validation data
Microbiological method Validation and re validation 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
Infotronicx Pharmasol 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.
Infotronicx Pharmasol 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.
This APQR Software will enables auto-versioning of PQR Document.
Infotronicx Pharmasol APQR Solution will auto calculation of Mean, Median and Standard Deviations.
Auto Generation of CPK (Process Capability Index)
Infotronicx Pharmasol APQR Software will shows the comparison between current to Previous Year Data
If you would like to discuss how your business can benefit from Infotronicx Pharmasol APQR Software, please contact us.