For Pharmaceuticals:

Seven Critical Concepts of the FDA’s Quality Systems Guidance

FDA Issues Final Guidance on Quality Systems Approach

From the discovery of penicillin in the late 1920s to the breakthrough anti-cholesterol and anti-HIV drugs being manufactured today, the pharmaceutical industry has always been in the front line of developing new technologies. But the industry has yet to fully embrace modern quality systems operations.

The FDA recently finalized a guidance to help pharmaceutical companies operate modern quality systems that are fully compliant with Current Good Manufacturing Practice (CGMP) regulations. The guidance is meant to encourage industry adoption of new technological advances and integrated quality systems, according to Dr. Janet Woodcock, FDA deputy commissioner and chief medical officer. The final guidance, which applies to manufacturing of drug products and components, was issued by the agency last September.

Called “Guidance on Quality Systems Approach to Pharmaceutical CGMP Regulations,” the document is meant to bridge the gap between the 1978 CGMP regulations and current quality systems and risk management approach. By following the guidance, manufacturers will be able to make technological advancements in their operations more readily, with appropriate regulatory oversight. More importantly, the FDA is hoping that by following the guidance, manufacturers will be able to produce drugs more efficiently and at a lower cost.

Seven Critical Concepts
The guidance identifies seven concepts critical for modern quality systems:

  • Quality: Refers to the strength, purity, and other quality characteristics meant to ensure a drug product’s safety and effectiveness.

  • Quality by Design and Product Development: Designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality.

  • Quality Risk Management: This includes assessing the risks of quality issues, selecting and implementing risk management controls commensurate with the level of risk, and evaluating the results of the risk management efforts. 

  • Corrective Action and Preventive Action (CAPA): Focuses on investigating, understanding, and correcting discrepancies while trying to prevent their recurrence.

  • Change Control: Managing change to prevent unintended consequences.

  • Quality Unit: A group within an organization that promotes quality in general practice.

  • Six-System Inspection Model: A model that can help pharmaceutical manufacturers comply with CGMP regulations. The six systems referred to in this inspection model are: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.


Learn more about this guidance::


FDA’s Quality Systems Approach to Pharmaceutical CGMPs

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FDA Link

  • Final Guidance – Quality Systems Approach to Pharmaceutical CGMP

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