21 CFR part 820 - Medical Device GMP

Medical Device manufacturers in the USA and foreign manufacturers who distribute their Medical devices in the USA must comply with GMP regulations. The manufacturer must implement a quality system in the organization, which helps ensure the devices meet or exceed the quality requirements and are safe and effective for the intended use. FDA site inspection is conducted against 21 CFR 820 requirements; after inspection, if any non-conformities are observed, FDA will issue an FDA 483 form with observations.

The GMP requirements are described in 21 CFR Part 820, which are similar to the international standard ISO 13485. Unlike ISO 13485 or CE Marking, there is no certification for GMP.

The sections in quality system regulations are

• 21 CFR 820 Subpart A - General Provisions
• 21 CFR 820 Subpart B - Quality System Requirements
• 21 CFR 820 Subpart C - Design Controls
• 21 CFR 820 Subpart D - Document Controls
• 21 CFR 820 Subpart E - Purchasing Controls
• 21 CFR 820 Subpart F - Identification and Traceability
• 21 CFR 820 Subpart G - Production and Process Controls
• 21 CFR 820 Subpart H - Acceptance Activities
• 21 CFR 820 Subpart I - Nonconforming Product
• 21 CFR 820 Subpart J - Corrective and Preventive Action
• 21 CFR 820 Subpart K - Labeling and Packaging Control
• 21 CFR 820 Subpart L - Handling, Storage, Distribution, and Installation
• 21 CFR 820 Subpart M - Records
• 21 CFR 820 Subpart N - Servicing
• 21 CFR 820 Subpart O - Statistical Techniques

(Source U.S. Food and Drug Administration)

LMG assists in

• GAP Analysis
• Facility design and environmental controls
• Documentation
• Internal Audit
• Implementation
• FDA pre-audit and post-audit support

If interested, please contact us with detailed information for an approximate budgetary quote.