Medical Device GMP

The US Food and Drug Administration (FDA) requires Medical Device manufacturers in the USA and foreign manufacturers who distribute their Medical devices in the USA are compliant with a quality system regulation called Medical Device GMP (Good Manufacturing Practice). These are regulatory requirements specified in 21 CFR Part 820.

These are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of devices. These guidelines provide the minimum requirements that a manufacturer must meet to assure that their products are consistently high quality, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent any harm from occurring to the end-user. Additional tenets include ensuring the product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.

Medical Device GMP

GMPs are overseen by regulatory agencies in various countries.  In the United States, GMP is enforced by the US FDA, but the FDA does not issue a GMP certificate nor does the FDA recognize one issued by a third-party certification body. The FDA does site audits and inspections based on 21 CFR 820. After inspection, if any non-conformities are observed, the FDA will issue an FDA 483 form with observations. The GMP requirements are described in 21 CFR Part 820, which are similar to international standard ISO 13485. Unlike ISO 13485 or CE Marking, there is no certification for GMP.

SECTIONS IN 21 CFR 820

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)

INTEGRATING MEDICAL DEVICE GMP & ISO 13485

The US FDA Medical Device GMP and ISO 13485 are more or less the same and the implementation of one system can help you achieve the other. Integrating multiple quality management systems has many advantages.

A medical device company may choose to implement ISO 9001, US FDA medical device GMP (21 CFR 820), and ISO 13485 standards together if they are seeking to do business in various global markets like the US, Europe, and other parts of the world.

The implementation of multiple systems at the same time helps you avoid developing and maintaining multiple lists of quality management system documents.

By choosing a European notification body for ISO 13485 Certification, It allows you to save time and money. (Choosing the same registrar (certification body) for ISO 13485 Certification and CE Marking will help you avoid two separate audits).

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