Annual Product Quality Review in Pharmaceutical Companies
The Pharmaceuticals, biotechnology manufacturing companies’ annual product quality review uses excel spreadsheets and other legacy systems for data analysis, but it is very time consuming, cumbersome and labor intensive and requires a lot of efforts and manpower to produce annual quality review reports. Annual Product Quality Review (APQR) or Product Quality Review (PQR) is a Good Manufacturing Process (GMP) requirement used to verify the consistency of the existing manufacturing process, meeting predetermined technical specifications, test methods and other quality attributes of a finished drug product. It plays a critical role in identifying any trends in the process further leading to process and product improvements.
Annual Product Quality Review is prepared in drug manufacturing companies to review the consistency of the products annually regarding their quality including change controls, out of specifications, market complaints, recalls and change controls etc. It is designed to minimize the drug product defects and also the risks associated with the manufacturing of the each pharmaceutical product.
Importance of Annual Product Quality Review
- Verifying the consistency of the existing processes and the appropriateness of specifications for both starting raw materials and finished drug product.
- It determines the quality, product defects in the process and possible improvements of the test methods and the trend of yield, analytical results, and manufacturing parameters of the drug product are also highlighted
- It reviews the quality of the raw material and packaging material which is used for the manufacturing of drug product
- The determination of the corrective action and preventive actions and their impact on product quality are also reviewed
- Out of specification (OOS) parameter helps to determine any product defects.
AmpleLogic Product Quality Review Software
To avoid the use of manual excel spreadsheets and other legacy systems for preparing and reviewing the annual product quality review and analysis, the AmpleLogic Product Quality Review (PQR) software system can help pharmaceutical, biotech and other drug manufacturing companies to quickly produce annual product quality review and analysis . The data analysis work time can be reduced to day instead of months, reducing the involvement of manpower, improving efficiency and saving workload.
AmpleLogic PQR Software provides the feasibility of excel import for uploading the bulk amount of data into the system with a single click of button. The users can easily customize and configure the reports according to the organization requirements. This system can be integrated seamlessly with statistical tools, ERP, LIMS and other existing applications.