Automating Annual Product Quality Reviews (APQR / PQR): Statistical Process Capability, Trend Analysis & Regulatory Compliance

Under US FDA 21 CFR §211.180(e), EU GMP Chapter 6, and CDSCO Schedule M, pharmaceutical manufacturers must conduct annual product quality reviews for every licensed drug product. The objective is to verify process consistency, assess raw material and packaging trends, evaluate critical quality attributes (CQAs), and highlight opportunities for continuous improvement.

In organizations using fragmented software tools, preparing a single APQR takes 6 to 12 weeks of manual data copying from batch registers, QC logbooks, deviation trackers, and stability spreadsheets. This introduces transcription errors and delays critical regulatory filings.

On the Novaqis unified platform, APQR reporting aggregates data instantaneously across all modules.

Novaqis APQR automates statistical computations across all commercial batches manufactured in the review year: • Process Capability Metrics: Automated calculation of Mean, Standard Deviation, Process Capability (Cp), and Minimum Process Capability (Cpk) for assay, dissolution, hardness, and degradation products. • Control Charts (Shewhart / Western Electric Rules): Visual detection of 1-point outside 3-sigma, 9 consecutive points on one side of the center line, or 6 consecutive points steadily increasing or decreasing. • Comprehensive Multi-Modular Synthesis: Instant consolidation of all deviations, change controls, OOS investigations, customer complaints, and stability timepoints into an inspection-ready dossier.