Pharmaceutical companies are required to submit a full Product Review (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.
Hence, to mitigate all such hassle, PQR Software, developed by Sarjen System offers automation and digitization of this manual process. PQR is a dossier which captures all the information about each batch of every product produced round the year. It turns the multipart Product Quality Review process into a relax manner. It abstracts, scrubs, and sorts large complex data from various departments and other ERP system which may be used by the company to provide key executive analytics.
Manual process takes lot of resources, time, and efforts go into its groundwork. Moreover, it takes hefty of time to prepare it. The process of generating an APQR/PQR becomes complex as it is a long-drawn, laborious and prone to errors. In other words, an area practically begging for automation of the process.
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.
PQR helps to assess changes required in the product specifications, manufacturing instructions, or other through change control procedures.
Key Data Captured
- Information relevant to batches which include product code, shelf life, date of manufacture and date of expiry along with pack size
- Batch failure or Rejections
- Out of specification and out of trend results
- Product returns, Market complaints, Product recalls
- Product Related CAPA’s and Deviations
- Equipment, instruments and utilities involved in the manufacturing procedure of the product
- Qualification status
- Change requests
- Temperature and humidity records
- Raw material, and packaging materials
- Process control and Analytical test results
- Marketing authorization and details of market variations like changes in the label
- Details and Specifications of the manufacture of packaging materials.
- Auto generates 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
- 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