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The FDA recently nalized 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 ofcer. The nal
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 efciently and at a lower cost.
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 predened 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.
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.
FDA Link
Additional Article
Quality Systems Guidance Spurs Improvement Full Article
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