Bharat Serums Accelerates Annual Product Quality Review (APQR) by 3x

Bharat Serums and Vaccines Limited (BSV) is a leading global biopharmaceutical company specializing in reproductive health, critical care, dermatology, and biosimilar products. As a regulated manufacturer with an extensive product portfolio, BSV was required to conduct Annual Product Quality Reviews (APQR) for each marketed product — a process that previously consumed months of manual effort from quality, production, and laboratory teams.

AmpleLogic's APQR software automated BSV's annual review process end-to-end. The platform automatically aggregated batch manufacturing data, laboratory results, stability data, deviation trends, CAPA statuses, and complaint volumes from integrated source systems, eliminating the manual data collection phase that had previously been the most time-consuming part of the review cycle.

Statistical analysis tools built into the platform — including control charts, trend analysis, and process capability calculations (Cp and Cpk) — ran automatically on the collected data, flagging out-of-trend results and generating statistical summaries that reviewers could validate rather than calculate from scratch. The system then assembled this information into a structured APQR report in the approved format, ready for quality team review and approval.

BSV reduced their APQR cycle time by a factor of three, completing reviews in weeks rather than months. The data-driven insights also improved the quality of the reviews themselves — reviewers spent more time analyzing trends and driving improvements, and less time on data collection and formatting. Regulatory submissions became more consistent and comprehensive as a result.