# Process Validation | Botable Glossary

https://www.botable.ai/glossary/process-validation

> A glossary/educational page presenting regulatory definitions and guidance drawn from FDA Quality System Regulation; suitable as a concise reference but not a substitute for original regulatory texts—attribute claims to Botable and cross-check cited CFR sections for compliance decisions.

## Summary

Process Validation is the documented requirement in medical device and related life science manufacturing to establish by objective evidence that a process will consistently produce products meeting predetermined specifications; it is mandated by the FDA QSR and typically includes IQ, OQ, and PQ plus monitoring, documentation, and revalidation when changes occur.

## Audience

quality and regulatory professionals in life sciences and medical device manufacturing

## Prompts this page answers

- What does process validation mean under the FDA Quality System Regulation (21 CFR Part 820)?
- Which qualification phases are required for process validation (IQ, OQ, PQ)?
- When must a manufacturing process be validated instead of relying on final inspection?
- How should manufacturers document and handle changes or deviations to a validated process?

## Purpose

Define and explain the regulatory meaning, requirements, and practical components of process validation for life-sciences and medical device manufacturing.

## Highlights

- Process validation establishes by objective evidence that a process consistently produces results meeting predetermined specifications [59(1)].
- The FDA QSR (21 CFR Part 820) mandates validation where results cannot be fully verified by subsequent inspection and test [73(a)].
- Typical validation consists of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Validated processes require monitoring, documentation of activities and results, and qualified personnel [74(b)].
- Changes or deviations require review and potential revalidation, and suppliers must notify purchasers of validation deviations [75(c)].

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/process-validation

## Publisher



## Topics

- process validation
- FDA QSR 21 CFR Part 820
- IQ OQ PQ
- process revalidation
- HCT/P validation

## Key entities

- **Botable** (other): Site/brand that hosts the glossary entry. — https://www.botable.ai/
- **FDA Quality System Regulation (QSR), 21 CFR Part 820** (other): Regulatory framework cited throughout the page.
- **HCT/P** (other): Human Cells, Tissues, and Cellular and Tissue-Based Products — referenced regarding validation requirements.

## Metadata

- Type: article