Course NameLength
cGMP Training | Current Good Manufacturing Practices Training3 days
FDA cGMP, QSR and ISO Certifications for Medical Devices3 days
FDA Cybersecurity Premarket Workshop2 days
FDA General Principles of Software Validation Workshop2 days

FDA  cGMP, QSR and ISO Certifications

The quality system regulations (QSR) for the U.S. Food and Drug Administration (FDA) regulated products are known as current good manufacturing practices (CGMP). 

These requirements were first implemented in 1978 under the Federal Food, Drug and Cosmetic Act and defined in section 21 part 820 of the Code of Federal Regulations (21 CFR part 820).

For over a decade, these regulations primarily focused on manufacturing of medical devices.  This changed with the Safe Medical Devices Act of 1990, which included product design controls. At the same time, the FDA sought to harmonize the CGMP regulations with applicable international standards.  The primary standards included International Organization for Standards (ISO) 9001:1994 and 13485:1996.

The ISO 9001 standard was entitled Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation, and Servicing.  The ISO 13485 standard was entitled Quality Systems – Medical Devices – Supplementary Requirements to ISO 9001. 

Whereas ISO 9001 emphasizes continual improvement and customer satisfaction, 13485 encompasses the requirements that medical device manufacturers must incorporate into their management systems.  These include maintaining effective processes while meeting regulatory requirements, customer requirements and managing risks.

A manufacturer that is certified to ISO 13485 does not inherently fulfill the FDA regulatory requirements.  However, this certification aligns the company management systems with requirements of the FDA’s QSR and international regulatory requirements. 

As such, 13485 provides a management system that serves as a framework for compliance to various regulatory and customer requirements.

The ISO and QSR systems each describe specific GMP standards. The ISO system pays more attention to the management of the firm and places a number of reporting loops in the firm to ensure attention to issues.

The QSR system is more focused on the manufacturing systems, and the validation of those systems. Although neither standard is required to maintain GMP facilities, it is essential that a firm satisfies the requirements of the client’s quality system. Generally, this means conforming to ISO or QSR standards.

Tonex offers four comprehensive, hard to find courses on the FDA’s quality systems regulations.

For more information, questions, comments, contact us.

FDA  cGMP, QSR and ISO Certifications