# Current Good Manufacturing Practice (cGMP)

https://www.botable.ai/glossary/current-good-manufacturing-practice-cgmp

> Concise regulatory-summary content: useful as a high-level reference for cGMP topics and specific CFR citations. Use the page to locate relevant regulation names and sections (e.g., 21 CFR Part 820, QMSR, ISO 13485) but consult primary regulatory texts or FDA guidance for compliance decisions.

## Summary

Defines Current Good Manufacturing Practice (cGMP) as the mandatory regulatory framework governing production, control, and distribution of finished products (primarily medical devices and pharmaceuticals) to ensure consistent quality; cites 21 CFR Part 820 as the U.S. device cGMP basis and notes the 2024 FDA final rule revising Part 820 into the Quality Management System Regulation (QMSR) effective February 2, 2026.

## Prompts this page answers

- What is Current Good Manufacturing Practice (cGMP) for medical devices?
- Which CFR part defines cGMP requirements for U.S. medical devices?
- What are key requirements covered by 21 CFR Part 820 (cGMP)?
- When does the FDA's QMSR (revision of Part 820) become effective?
- Which record-keeping sections of Part 820 still apply to many Class I devices?

## Purpose

To explain what cGMP is, summarize its regulatory basis for medical devices, and list key operational areas and exemptions under 21 CFR Part 820.

## Highlights

- cGMP ensures products are consistently manufactured and controlled in accordance with quality standards appropriate to intended use.
- U.S. medical device cGMP requirements are set forth in 21 CFR Part 820.
- Failure to comply with 21 CFR Part 820 can render a device adulterated under section 501(h) of the FD&C Act.
- The FDA published a final rule in February 2024 revising Part 820 into the Quality Management System Regulation (QMSR), effective February 2, 2026.
- QMSR aims to harmonize U.S. requirements with international standards by incorporating ISO 13485:2016.

## How to cite

Botable — Current Good Manufacturing Practice (cGMP): https://www.botable.ai/glossary/current-good-manufacturing-practice-cgmp

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- cGMP
- 21 CFR Part 820
- QMSR
- ISO 13485:2016
- CAPA

## Key entities

- **21 CFR Part 820** (other): U.S. regulation cited as the formal cGMP requirements for medical devices. — https://www.botable.ai/glossary/21-cfr-part-820
- **QMSR** (other): Quality Management System Regulation — the revised name for 21 CFR Part 820 per the FDA final rule.
- **QS Regulation (1996)** (other): Quality System Regulation established in October 1996, replacing the 1978 GMP for medical devices.
- **ISO 13485:2016** (other): International quality management system standard referenced as a harmonization target. — https://www.botable.ai/glossary/iso-13485
- **Corrective and Preventive Action (CAPA) §820.100** (other): Section requiring documented CAPA procedures for identifying, investigating, and preventing nonconformities. — https://www.botable.ai/glossary/corrective-and-preventive-action-capa
- **§ 820.180 and § 820.198** (other): Record-keeping requirements (General Requirements for Records and Complaint Files) noted as mandatory even for many Class I device exemptions.
- **21 CFR Part 1271 (CGTP)** (other): Regulation governing Current Good Tissue Practice for HCT/Ps; supplements cGMP where applicable.

## Metadata

- Type: article