CPV & APQR

CPV SOPs & Policy Documents

We author robust CPV standard operating procedures (SOPs) or site-specific policy documents that define scope, data sources, roles, and statistical methodologies.

• CPV governance framework

• Alignment with FDA/EMA lifecycle validation guidelines

• Integration with Quality Management Systems (QMS)

CPV Plans by Unit Operation

We create tailored CPV plans for each unit operation—linking critical process parameters (CPPs), in-process controls (IPCs), and quality attributes to control strategies.

• Unit-specific data plans for DS/DP operations

• Acceptance limits, trending frequency, and alert rules

• Data source mapping (MES, LIMS, SCADA)

CPV Reports

We generate periodic CPV reports that summarize statistical control, parameter trends, process capability, and deviation history.

• Control charts, capability indices (Cpk/Ppk)

• Data roll-up across batches and time points

• Action triggers and risk escalation summaries

Running CPV Meetings

We facilitate recurring CPV data review meetings to interpret trends, drive cross-functional decisions, and ensure timely follow-up on signals.

• CPV dashboards and slide deck preparation

• SME-led discussions on trends and OOTs

• Linking of findings to CAPA and process improvements

APQR (Annual Product Quality Review) Reports

We support or author APQRs that integrate CPV data to provide holistic product and process performance summaries.

• Integration of batch records, deviations, complaints, and CPV data

• Lifecycle trend evaluation

• Regulatory inspection readiness