--- title: "Process Validation, Definition | MedTech Terms" description: "Establishing documented evidence that a process consistently produces conforming output. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. Process Validation [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply) # Process Validation Establishing documented evidence that a process consistently produces conforming output. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/mdr-reporting) 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](/terms/iso-11137) for radiation [sterilization](/terms/sterilization) or [ISO 17665](/terms/iso-17665) for moist heat sterilization. ## What this means in practice [Sterilization](/terms/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 What is the primary goal of process validation? The primary goal is to ensure that a manufacturing process consistently produces a product that meets its predetermined specifications and quality attributes. When is process validation typically required? What are the three main stages of process validation? Can software be validated as part of a process? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Design Transfer Translating design into production specifications. ](/terms/design-transfer) ### Manufacturing & Supply Chain · From this learning path [ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). ](/terms/cleanroom-iso-14644?from=manufacturing-and-supply-chain)[ Quality & Risk IQ / OQ / PQ Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification. Adjacent lesson ](/terms/iq-oq-pq?from=manufacturing-and-supply-chain)[ Manufacturing Lot Traceability Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number. ](/terms/lot-traceability?from=manufacturing-and-supply-chain)[ Manufacturing Stability Testing Studies that establish how device performance and packaging hold up over time. ](/terms/stability-testing?from=manufacturing-and-supply-chain) ### More in Manufacturing · Same category [ Manufacturing Sterilization Validated process used to render a device free from viable microorganisms. ](/terms/sterilization)[ Manufacturing Supplier Controls Procedures to ensure purchased products and services conform to requirements. ](/terms/supplier-controls)[ Manufacturing Bill of Materials(BOM) Structured list of every component, sub-assembly, and quantity needed to manufacture a device. ](/terms/bom) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Manufacturing & Supply Chain](/paths/manufacturing-and-supply-chain)Lesson 1 of 14 Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 GHTF/IMDRF· 1 ISO· 1 FDA· 1 1. [1 GHTF SG3 Process Validation Guidance Verified GHTF/IMDRF · imdrf.org ](https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf) 2. [2 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) 3. [3 FDA - Device Manufacturing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Manufacturing Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=process-validation) Learn in 60 seconds Card Lesson Quiz Establishing documented evidence that a process consistently produces conforming output. - · Sterilization, injection molding, and software-controlled assembly are common validated processes. Remember this Watch out: Confusing process validation with design validation, which focuses on validating the device design meets user needs and intended uses. Related terms - [Design Transfer ](/terms/design-transfer) You may also need Auto-suggested from Manufacturing and shared keywords. - [IQ / OQ / PQ ](/terms/iq-oq-pq) - [Technology Transfer (Manufacturing) ](/terms/tech-transfer) - [Device Master Record(DMR) ](/terms/dmr) - [Process Capability (Cp/Cpk) and SPC ](/terms/spc-cpk) - [Process Capability and Cpk ](/terms/process-capability-cpk) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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