Process validation consulting
Process characterization and qualification across formulation, filling, and packaging. We identify what matters to product quality, qualify the process, and set up the monitoring that keeps it in control.
The three stages of process validation
FDA describes process validation as a lifecycle with three stages: process design, process qualification, and continued process verification. Each stage builds evidence that the process can reliably make product that meets its quality attributes.
We support all three. In design, we help identify critical quality attributes (CQAs) and the critical process parameters (CPPs) that drive them. In qualification, we write and execute process performance qualification (PPQ) protocols with statistically justified sampling. Afterward, we set up continued process verification so drift is caught early.
Filling, packaging, and serialization
Packaging is where many deviations begin. We qualify filling and packaging operations with AQL-based sampling plans per ANSI/ASQ Z1.4 and validate serialization and aggregation systems for DSCSA compliance.
Protocols are written in your templates with clear acceptance criteria, so your QA group can approve them without repeated rewrites.
What we deliver
- Process risk assessments and control strategies
- CPP and CQA identification
- PPQ protocols, execution, and reports
- Sampling plans per ANSI/ASQ Z1.4
- Continued process verification plans
- Packaging line and serialization validation
- Master batch and packaging records
Regulations and standards
- 21 CFR 211.100 and 211.110
- FDA process validation guidance
- ICH Q8, Q9, and Q10
- ANSI/ASQ Z1.4
- DSCSA
Common questions
How many PPQ batches are required?
No regulation sets a number. Three batches is a common convention, but FDA expects the number to be justified by process understanding, variability, and risk. We help document that rationale in the PPQ protocol.
What is continued process verification?
It is the ongoing collection and trending of process and quality data after PPQ, to confirm the process stays in a state of control during routine production. It usually takes the form of a monitoring plan with defined parameters, review frequency, and response rules.
Do legacy products need process validation?
Yes. Products made before current expectations still need documented evidence of control. A retrospective data review combined with a continued process verification plan is often the most practical route.
Other services
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.