Quality System Regulation 21 CFR Part 820 (CGMP)

Dating back to October 1996, CFR Part 820 is the FDA's regulation defining Current Good Manufacturing Practices for Medical Devices. Some level of QSR compliance is required for all medical device manufacturers dealing with devices of risk classifications other than Class I exempt. This includes both domestic as well as foreign manufacturers.

For higher risk devices, the level of compliance is 100%, including the need for well-documented management, design and manufacturing controls. Other critical control processes include purchasing, identification & traceability, acceptance activities, nonconforming product, CAPA, labelling & packaging, handling-storage-distribution, records, servicing and statistical techniques.

For domestic and foreign manufacturers alike, the challenge is often to determine compliance internally prior to the FDA inspection. When issues arise from an FDA insepction, the challenge then becomes one of investigation, root cause analysis and corrective/preventive action. In addition, recently there has been an increased focus on risk management within the design and development process as well as throughout production and post-production phases.

RA/QA International can be an invaluable resource in enabling you to achieve and maintain QSR compliance, effectively and efficiently.

Solution:

On-site training of your key staff members and internal auditors to ensure thorough understanding of requirements of the QSR and its harmonization with ISO 13485.

Documentation analysis, on-site gap analysis and facilitation of corrective actions to ensure a streamlined yet effective quality management system to comply with 21 CFR Part 820. Note: Typically we are also requested to analyze current levels of compliance to ISO 13485:2003 and ISO 14971:2000 as well.

Internal auditing of your facility to ensure independence and ongoing compliance