The U.S. Food and Drug Administration's (FDA) current good manufacturing practice (cGMP) regulations are meant to ensure that pharmaceutical drugs are consistently produced and controlled according to quality standards, are safe for use and work as intended. Quality and compliance software helps manufacturers adequately address GMP compliance.
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The FDA devised cGMP regulations to establish a foundation of requirements for drug product quality and enable a common understanding of the regulatory process. Compliance with the cGMP regulations requires that manufacturers adequately control manufacturing operations. This includes establishing a strong QMS and robust operating procedures, and identifying and addressing product quality deviations. The GMP guidelines are minimum requirements, with enough flexibility to allow manufacturers to determine the best methods of implementing the necessary controls. The flexibility allows companies to use modern technologies and approaches to achieve greater quality through continuous improvement.
In its "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations," the FDA identified seven concepts critical for modern quality systems.
Pharmaceutical products must establish identity, strength and other quality characteristics meant to ensure the required levels of safety and effectiveness.
Quality by design, in conjunction with a quality system, provides a sound framework for sharing product knowledge and process understanding.
Quality risk management is a valuable part of an effective quality system framework. It includes implementing risk management controls commensurate with the level of risk.
CAPA as a cGMP regulatory concept focuses on investigating, understanding and correcting discrepancies while trying to prevent their recurrence.
Change control focuses on managing change to prevent unintended consequences. Effective change control is a key part of any quality system.
The quality unit refers to a group within an organization that promotes quality in general practice. Current industry practice generally divides the responsibilities of the unit between quality control (QC) and quality assurance (QA) functions.
The six-system inspection model can help pharmaceutical manufacturers comply with cGMP regulations. It is composed of quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.
MasterControl and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Discover what it takes to meet the FDA's pharmaceutical GMP compliance system requirements.Download the Q&A