Glossary · GxP: good practices
Process validation
Also known as: PV, Validation of manufacturing processes, Validation of processes for production
Process validation is the documented evidence that a manufacturing process, operated within established parameters, consistently produces a product meeting its predetermined specifications and quality attributes. In pharma it is required by EU GMP (Annex 15) and US cGMP; for medical devices, ISO 13485 requires validation of processes whose output cannot be or is not verified by subsequent monitoring or measurement.
- GxP
- Pharma
- MDR
In one sentence
Process validation shows that a manufacturing process consistently yields product to specification; required by EU GMP Annex 15, US cGMP and ISO 13485.
Example
A device manufacturer validates the heat sealing of sterile barrier pouches, because seal integrity cannot be fully tested on every pouch without destroying it; it sets parameter ranges, runs qualification lots and monitors the process afterwards.
How it applies
- Lifecycle: The FDA's 2011 guidance describes three stages: process design, process qualification and continued process verification. Annex 15 allows traditional validation, continuous process verification and hybrid approaches.
- Pharma: Development knowledge under ICH Q8(R2) — critical quality attributes and critical process parameters — defines what validation has to show.
- Medical devices: Typical validated processes are sterilization (ISO 11135 and ISO 11137), sealing, welding, molding and software used in production. Validation is part of the QMS evidence under ISO 13485 and the MDR.
- Revalidation: Changes to process, equipment, materials or site are assessed under change control and may require revalidation.
- Technical documentation: A validation master plan, protocols with acceptance criteria, reports and ongoing monitoring data form the record; the device technical documentation refers to the manufacturing and validation information.
Process validation vs. product verification
Verification checks that a given output meets requirements, for example by testing each part. Process validation is needed where such checks are not possible or not done for every unit, so confidence must come from the process itself. Where full verification is feasible and done, validation may not be required for that process.