--- title: "Production and Process Controls, Definition | MedTech Terms" description: "21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/production-process-controls#term", "name": "Production and Process Controls", "description": "Covers documented procedures, environmental control, contamination control, equipment maintenance, personnel hygiene, and process changes. 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Such processes require validation to ensure they consistently produce a conforming product." } }, { "@type": "Question", "name": "How often should production equipment be maintained and calibrated?", "acceptedAnswer": { "@type": "Answer", "text": "Equipment maintenance and calibration schedules should be established based on manufacturer recommendations, risk assessment, and historical data, and must be documented as per 21 CFR 820.72 and 820.70(g)." } }, { "@type": "Question", "name": "What is the role of 'contamination control' in Production and Process Controls?", "acceptedAnswer": { "@type": "Answer", "text": "Contamination control involves establishing procedures and environmental controls to prevent the introduction of unwanted substances or microorganisms that could adversely affect product quality or safety, particularly for sterile devices, as outlined in EU MDR Annex I, Sections 10.3 and 11.2." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Production and Process Controls [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system) # Production and Process Controls 21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Covers documented procedures, environmental control, contamination control, equipment maintenance, personnel hygiene, and process changes. The clauses where ' [process validation](/terms/process-validation)', 'in-process controls', and 'work instructions' all live. What the regulation says Production and Process Controls are mandated by regulations such as 21 CFR Part 820, specifically Subpart D for device design, Subpart E for purchasing and handling, Subpart F for identification and traceability, Subpart G for production and process controls, Subpart H for acceptance activities, and Subpart I for nonconforming product. These regulations require manufacturers to establish and maintain procedures to control production and processes to ensure that a device conforms to its specified requirements. The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) also emphasizes similar controls within its General Requirements for Safety and Performance (Annex I), particularly regarding manufacturing processes, sterility, and environmental control. ## What this means in practice Among the most frequently cited subparts in [FDA Form 483](/terms/form-483) observations. ## Examples - A manufacturer of sterile surgical instruments must validate its sterilization process to ensure all product-contact surfaces are free of viable microorganisms, as required by ISO 11135. - A company producing implantable devices must maintain strict environmental controls in its cleanroom facility to prevent particulate contamination, aligning with ISO 14644 series. - Before implementing a new automated assembly machine, a MedTech company must perform process validation to confirm it consistently produces devices meeting specifications, as per 21 CFR 820.75. Common pitfalls - • Failing to validate all processes, even those not considered "special processes," can lead to non-conformities. - • Inadequate documentation of process changes, including justifications and verification activities, is a common deficiency. - • Not consistently monitoring and controlling environmental conditions, especially in cleanroom environments, can compromise product quality. - • Neglecting routine equipment calibration and maintenance can directly impact process stability and product conformity. - • Assuming personnel are adequately trained without documented evidence of their competency in specific production tasks is a critical oversight. ## Frequently asked questions What is a 'special process' in the context of Production and Process Controls? A special process is one where the output cannot be fully verified by subsequent inspection and testing, and any deficiencies only become apparent after the device is in use. Such processes require validation to ensure they consistently produce a conforming product. How often should production equipment be maintained and calibrated? What is the role of 'contamination control' in Production and Process Controls? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Process Validation Establishing documented evidence that a process consistently produces conforming output. ](/terms/process-validation) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 ISO· 1 1. [1 21 CFR 820.70 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [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 Quality & Risk Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=production-process-controls) Learn in 60 seconds Card Lesson Quiz 21 CFR 820.70 / ISO 13485 §7.5 requirements that production processes be planned, controlled, monitored, and validated where needed. - · Among the most frequently cited subparts in FDA Form 483 observations. - · The clauses where 'process validation', 'in-process controls', and 'work instructions' all live. Remember this Watch out: Failing to validate all processes, even those not considered "special processes," can lead to non-conformities. Related terms - [Process Validation ](/terms/process-validation) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Technology Transfer (Manufacturing) ](/terms/tech-transfer) - [Design Controls ](/terms/design-controls) - [Change Control ](/terms/change-control) - [Quality Manual ](/terms/quality-manual) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Post-Production Information (Risk) ](/terms/post-production-info) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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