EN
PLContext:
A Quality Assurance (QA) specialist in a pharmaceutical company is responsible for the periodic statistical evaluation of medicinal products as part of Ongoing Process Verification (OPV) / Continued Process Verification (CPV) and/or the Product Quality Review (PQR). This analysis is essential to demonstrate regulatory compliance and ensure consistent product quality. For a portfolio of more than 50 products, each with multiple Critical Quality Attributes (CQAs), annual reviews generate a significant analytical workload. QA specialists spend substantial time on repetitive, error-prone tasks such as copying data, formatting spreadsheets, generating charts and performing statistical calculations across various tools.
Purpose:
The purpose of using the StatSoft PQM application is to streamline and accelerate the assessment of process stability and capability for critical quality attributes (CQAs) across the entire product portfolio and create complete, standardized statistical reports for inspection and quality documentation purposes.
Application:
The Quality Control (QC) Department collects measurement data for critical quality attributes — such as assay, dissolution and impurities — for product batches manufactured throughout the year. These data are stored in Statistica, Excel spreadsheets or, preferably, in the dedicated StatSoft PQM-DB database.
The QA specialist imports data from the last 12 months from the selected source (Statistica, Excel or StatSoft PQM-DB) into the StatSoft PQM application, eliminating the need for manual data consolidation and formatting. Next, the specialist selects appropriate statistical methods from pre-configured templates, including descriptive statistics, control charts and process capability indices.
The application automatically generates a standardized, comprehensive and professionally formatted report containing all required analyses. The QA specialist reviews the results, formulates data-driven recommendations and finalizes the document for inclusion in the quality documentation.
Outcome:
Using the StatSoft PQM application, the QA specialist performed a complete statistical evaluation of critical quality attributes as part of the Product Quality Review, including analysis of process stability and process.
Benefits:
Time Efficiency: Statistical reports for process stability and capability evaluation prepared in minutes instead of hours, significantly reducing manual effort
Regulatory Compliance: Comprehensive, audit-ready documentation meeting OPV/CPV and PQR requirements
Data-Driven Decisions: Evidence-based recommendations supported by robust statistical analysis
Consistency: Standardized reporting format ensuring quality and reproducibility across all product reviews
Strategic value: Redirecting saved time to high-value activities: in-depth trend analysis, root cause investigation, and continuous improvement initiatives.