US FDA Good Manufacturing Practice

Quality System Regulations (QSR’s).

The FDA Quality System Regulations detail the good manufacturing practices that need to be implemented from product development into product processing and end use, for medical type products to ensure the delivery of a compliant, effective, conforming (to specification), consistently high quality product.

The QSR’s are enforced by regulatory bodies when assessing the ability of a manufacturer to consistently output product, that can achieve the medical benefit claims associated with their products.

The QSR’s while focussed on manufacturing impact the entire development and supply chain, from product development including clinical trial feedback, through raw material selection and sourcing, process development, qualification and validation, product release, distribution and use, including the gathering and analysis of customer use data.

Industries where the QSR’s are applied by regulatory bodies, include medical devices, pharmaceutical, food, bio-technology, i.e. those industries where a product or process failure, deficiencies with the constituent materials, failings within product formulation or within the manufacturing process, etc., can lead to human injury.


The Quality Systems Regulations (QSR’s) for Medical Devices as detailed in FDA 21 Part 820 CFR specifically define requirements for the following activities:


General requirements >>>

Quality Management and Organization >>>

Device design >>>

Control of Documentation >>>

Purchasing >>>

Identification and Traceability >>>

Production and process controls >>>

Acceptance activities >>>

Non conforming product >>>

Corrective and Preventative Action >>>

Packaging and Labeling control >>>

Handling, Storage, Distribution and Installation >>>

Record requirements >>>

Servicing >>>

Statistical Techniques >>>

Buildings and Facilities >>>

Equipment and Maintenance >>>

Complaint processes >>>

Medical Device Validation – Regulation. Requirements & current best Practices.

      • How to plan and implement a Validation program.
      • How to identify Validation requirements versus actual status.
      • The Life Cycle approach to Validation.
      • How to identify Validation Gaps and confirm Validation effectivity.
      • Reporting on the outcomes of Validations performed.
      • Use to develop your personal understanding.
      • Use as a support if providing training.
      • Details >>>

FDA approach to Medical Device Classification >>>

Preparing for an FDA Medical Device GMP Audit >>>

Medical Device Design Control >>>

ALARP concept in Risk Management >>>

Operational Risk Management >>>