Manufacturing Process Lifecycle
Design, Optimize, and Control Processes
Support for the Manufacturing Process Lifecycle
BIOVIA Discoverant supports the entire manufacturing process lifecycle from process development through scale-up and tech transfer to final production. BIOVIA Discoverant helps you with:
- Process Design -- Understand critical process parameters to improve the design of robust GMP processes
- Process Optimization -- Identify and reduce sources of product and process variability
- Process Control -- Monitor variability with immediate visibility into process performance, quality and compliance risk
Understand Critical Process Parameters
- Identify Critical Process Parameters (CPP), operating ranges and Critical Quality Attributes.
- Scale up and transfer processes to new lines/products supporting Quality by Design.
Identify Process and Product Variability
- Find, reduce and control sources of variability to optimize processes
- Accelerate preparation and approval of ongoing submissions for Scale-Up and Post-Approval Changes (SUPAC).
- Predict future out-of-trend (OOT) or out-of-specification (OOS) events to minimize downtimes and costs
Control and Report Process Performance
- Continuously monitor and verify process performance with Continued Process Verification (CPV)
- Rapidly create reports for:
- Annual Product Quality Reviews, (APQR), Annual Product Reviews, (APR), Product Quality Reviews (PQR)
- Stability and shelf-life expiration
- Address process and quality problems before failures occur
Supported Initiatives
BIOVIA Discoverant provides visibility throughout the product lifecycle and supply chain. It helps predict and prevent potential issues with data-driven, root-cause analysis and supports initiatives like:
- Industry 4.0
- Operational / Manufacturing Excellence
- Quality by Design (QbD)
- Tech Transfer / Outsourcing
- Continued Process Verification (CPV)
- Process and Product Monitoring / Visibility
- Continuous Process Improvement (CPI)
- Manufacturing Process Improvement (MPI)
- Process Analytical Technology (PAT)
- FDA Quality Metrics Program
- Predictive Maintenance
- Right-First-Time
- Digital Transformation
Quality Metrics
With their "Submission of Quality Metrics Data“ guidance document, the FDA is planning to collect and analyze data from drug manufacturers on an annual basis, noting that the reports "can only be as good as the quality of available data and analytic tools." BIOVIA Discoverant provides Quality Metrics on demand in a validation-ready environment, supporting adherence to quality metrics reporting guidelines with automation. It includes Lot Acceptance Rate (LAR), Product Quality Complaint Rate (PQCR) and Invalidated Out-Of-Specification (OOS) Rate reports. A scalable infrastructure for process improvement significantly reduces overhead effort.
Continuous Process Verification
CPV is the third stage of process validation for continuously monitoring processes throughout the lifetime of the product. The goal is to maintain the process in a state of control and meet the requirements set for the product, while helping to ensure final product quality.
BIOVIA Discoverant provides role-based Process and Product Monitoring (PPM) with automated alerts enabling review-by-exception to improve process performance and compliance with CPV. Proactive warnings allow you to take action before batches fail.
Capabilities
- Process trending for early warning of out-of-control conditions
- Automatic updates and email alerts for monitoring by exception
- Process capability analysis to determine whether a process meets specifications
- Feature Extraction capabilities to include complex continuous process and quality parameters in a monitoring program
- Ad hoc cause-and-effect analytics and reporting to investigate adverse trends and identify process improvement opportunities
- Event tri-panel plot with CUSUM plot for root cause analysis
- 17 unique single and combination control charts including Variable and Attribute Charts and Assumption Tests
- Automatic calculation of summary statistics for time series and other data types
- High-level batch reports indicating whether parameters passed or failed specification
Read: Process & Product Monitoring Datasheet
CPV Support
BIOVIA also supports CPV initiatives with a dedicated Professional Services team supporting the customer from project initiation through full process understanding. In this way, you can speed value realization, user adoption and regulatory compliance with industry best practices, while also aligning the solution to your specific requirements.
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