How can Automation help preparing APQR in one day?

What is PQR or APQR in pharma?

Annual Product Quality Review or Product Quality Review  can be identified as a manoeuvring and compilation of data from various dimensions involved in product manufacturing to display the quality of product. It includes various useful and meaningful trends to draw out inferences and summarize the evaluation of data in various aspects.

How to prepare APQR/PQR

APQR is prepared annually for each product to give an insight of product quality and provide a larger view to company in terms of Yield, Safety, Cost, Processes, etc. It displays the health of the product and suitability of facility to manage the production of product. PQR/APQR is also a regulatory requirement.

APQR/ PQR covers analyses and inference of below described elements (but not limited to)

• Technical Agreements / Quality Agreements
• Regulatory Updates
• Marketing Authorization Variation
• Key Starting Materials (including Product Contact Packaging Materials)
• Equipment Qualification Status
• Environmental Control
• Facility Support Systems (Water, HVAC, Compressed Gases)
• GMP Observations
• Batch Manufacturing and Packaging Records
• Process Controls (CPPs and CQAs)
• Process Validation Review
• Product / Process related Changes
• Lab Product Testing (Finished Product results and Intermediate test results)
• Specification Review
• Test Method Validation
• Stability Data
• Retention Samples
• Follow up From Previous APQR
• Rejects -Yields – Deviations
• CAPAs
• OOS & OOTs
• Market Complaints
• Product Investigations
• Product Recall
• Adverse Drug Events (ADR/ADE)
• Product Returns
• Process Capability (Rework and Reprocessing)

What are the challenges of preparing PQR or APQR in pharma?

The vast data once gathered need to be combined in different permutation and combinations using excel sheets or other computer system for preparation of charts, tables and graphs to create various types of trends as per the predefined template of PQR/APQR. Hence, it is a troublesome activity and sometimes, a confusing process for the human resource as it involves transcription of data from the source document and preparation of charts.

Due to manual collection of data from various sources it takes about a months’ time to complete a product’s APQR. Even though the data may be compiled with errors because it was transcribed from various sources.

Automation in APQR preparation

This APQR in pharma preparation can be automated and digitalized to nullify the tiring efforts and minimising the chances of errors. Through automatic collection of data from various sources can make work easy and increase the accuracy in data gathering. Further, error during processing of charts and graphs can also be nullified using computerized system.

Sarjen System’s QEdge Software that also includes other QMS tools, apart from the APQR process, collects information from all required domains and presents required user-defined graphical trends. It also allows upload of data that are available in paper format, thus, increasing limits of data gathering to new horizons. So, whenever you need to prepare APQR, you just need to select the time period and generate the PQR and follow an approval cycle within the system.