Process Validation
We support clients at all stages of Process Validation (PV) through current risk-based approaches as part of a complete product lifecycle, ensuring processes are designed, qualified, and controlled to consistently produce robust products that meet regulatory expectations of safety, quality, identity, purity, and potency.
Areas of Expertise
Process validation strategies and development of process validation programs
Process validation master plans (PVMP)
Stage 1: Process design and process characterization support
Stage 2: Process performance qualification (PPQ protocol execution and reporting)
Stage 3: Continued process verification (CPV) programs
Risk assessments and control strategy integration
Protocol writing, execution, and summary reporting
Material qualification (extractables and leachables / excipient & raw materials assessments)
Reprocessing operations validation and sampling reduction strategies (from PPQ into commercial phase)
Systems & Processes Supported
Biologic upstream and downstream drug substance process performance
Hold time studies
Mixing validation
Drug product fill-finish operations
Oral solid dosage (OSD) manufacturing
Sterile manufacturing systems
Ancillary and support systems
Let Forza Pharma Consulting help validate your processes with precision and regulatory confidence.
