Pharmaceutical companies are required to submit a full Product Quality Review (PQR) or APQR in the U.S. and PQR in Europe to government health authorities annually, detailing key aspects of the manufacturing process for each drug they produce. APQR or PQR is a mandatory requirement that used to verify the consistency and appropriateness of an existing manufacturing process. It plays a critical role in identifying any trends in the process further leading to process or product improvements. It is an evaluation which is prepared according to the CGMP requirements of different regulatory authorities. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product the content.
Key Features PQR/ APQR
Auto generates Product Quality Review (PQR) document for every product manufactured as per the predefined template based on the selection of the start and end date
Auto Alerts in case of delays or upcoming activity
Dashboard can be designed at each profile user with respect to every activity that provide intelligence regarding each parameter
Allows users for controlled auto versioning of PQR document
In compliance with all major standards including 21 CFR PART 11 and EU Annex 11 Standards and defined by other regulatory bodies
Configurable workflow design as per current practice
Design and Configuration of master data
Batch wise trending reports for key data
Auto calculate Process Capability Index value
Comparison of data between current and previous year/s
Integrating with other software systems and any other ERPs
Benefits of Product Quality Review (PQR)
PQR goes beyond the basic regulatory requirements and provides users with organized analytics for critical functions. In doing this, it certainly promotes a value of continuous Product Quality Review. Below are a few benefits:
Improved compliance and reduced operating costs
Enhances accuracy, productivity and consistency
Access trending, productivity and other metrics, instantly
Improved decision making
Readily available key analytics within minutes as and when needed
Save massive amounts of time, resources, and effort
Ensure data integrity
Meet compliance standards set by regulatory authorities as all the data ingested is audit trailed for 21 CFR Part 11 compliance
Benefited across various business domains like Pharmaceuticals, life sciences, biologicals, manufacturing and packaging industries, medical devices etc.
