All terms
ManufacturingManufacturing & Supply
Process Validation
Establishing documented evidence that a process consistently produces conforming output.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Process validation per GHTF/SG3 covers Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to demonstrate process capability for specifications that cannot be fully verified by subsequent inspection or test. What the regulation says
Process validation is a key requirement for medical device manufacturers, as outlined by regulatory bodies like the FDA in 21 CFR part 820.75 and the EU MDR in Annex I, Section 10.2. This involves establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. For sterile devices, demonstrating sterility assurance through validation is critical, often referencing standards like ISO 11137 for radiation sterilization or ISO 17665 for moist heat sterilization.What this means in practice
Sterilization, injection molding, and software-controlled assembly are common validated processes.Examples
- A manufacturer validates an injection molding process to ensure that each molded component consistently meets critical dimensional and material property specifications.
- A medical device company validates its sterilization process using ethylene oxide to confirm that all devices achieve the required sterility assurance level.
- A pharmaceutical company validates its aseptic filling process to ensure that each vial is filled accurately and remains free from microbial contamination.
Common pitfalls
- •Confusing process validation with design validation, which focuses on validating the device design meets user needs and intended uses.
- •Failing to revalidate a process after significant changes to equipment, materials, or methods.
- •Not adequately documenting all validation activities, including protocols, results, and deviations.
- •Overlooking the need to validate supporting processes, such as cleaning or software used in manufacturing.
- •Treating process validation as a one-time event rather than an ongoing activity through process monitoring and control.
Frequently asked questions
The primary goal is to ensure that a manufacturing process consistently produces a product that meets its predetermined specifications and quality attributes.
Related terms
Shared paths + categoryManufacturing
Design Transfer
Translating design into production specifications.
Manufacturing & Supply Chain
Manufacturing
Cleanroom Classes (ISO 14644)
ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9).
Manufacturing & Supply Chain
Quality & Risk
IQ / OQ / PQ
Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification.
Manufacturing & Supply Chain · adjacent
Manufacturing
Lot Traceability
Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number.
Manufacturing & Supply Chain
Manufacturing
Stability Testing
Studies that establish how device performance and packaging hold up over time.
Manufacturing & Supply Chain
Manufacturing
Sterilization
Validated process used to render a device free from viable microorganisms.
Manufacturing & Supply Chain
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
GHTF/IMDRF·1ISO·1FDA·1
- 1GHTF SG3 Process Validation GuidanceVerifiedGHTF/IMDRFimdrf.org
- 2ISO 13485 Standard PageVerifiedISOiso.org
- 3FDA - Device ManufacturingVerifiedFDAfda.gov
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