cGMP Compliance

Overview
Good Manufacturing Practices (GMPs or cGMPs) are recognized worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products and medical devices. They for the basis for FDA's QS Regulation (QSR) contained in 21CFR Part 820 (for medical device manufacturers) and for 21 CFR Parts 210 and 211 (for pharmaceutical manufacturers). GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment ensuring documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. In addition, GMP requires that all manufacturing and testing equipment to be qualified as suitable for use, and that all operational methodologies and procedures, such as manufacturing, cleaning, and analytical testing, utilized in the manufacturing process to be validated according to predetermined specifications to demonstrate that they can perform their function.

The FDA enforces cGMP compliance in the US. In the European Union, GMP inspections are performed by National Regulatory Agencies in various coutries such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK . Each of the inspectorates carries out routine GMP inspections to ensure that drug and medical device products are produced safely and correctly. Moreover, many countries perform Pre-Approval Inspections (PAI) for cGMP compliance prior to the approval of every new product for marketing.

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MetricStream enables companies to take a risk-based approach to quality and compliance management and provides a common framework and an integrated approach to meet FDA cGMP regulations through risk management, document control, compliance training, ongoing auditing, recording and reporting of exception events and the resulting corrective actions as well as validation services.

cGMP Resources

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Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
The report explains the FDA's CGMPs for the 21st Century Initiative as well as the individual charges and achievements of the various working groups that have been involved in the initiative. The report also outlines FDAs path forward in implementing the pharmaceutical quality regulatory system for the future.

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FDA CDRH Good Manufacturing Practices (GMP) / Quality System Regulation (QSR)
The current Good Manufacturing Practice (GMP) requirements set forth in the FDA Quality System (QS) regulation require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements in the QS regulation.

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International Society for Pharmaceutical Engineering
ISPE is the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry. Founded in 1980, today ISPE serves more than 23,000 members in 90 countries.

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Regulatory Affairs Professionals Society
The Regulatory Affairs Professionals Society (RAPS) is the leading worldwide member organization devoted to the health product regulatory profession.

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News and Articles

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Optimizing Your Internal Process for FDA Compliance
The FDA has been releasing new guidelines to improve pharmaceutical product manufacturing quality and safety. One example is the FDA's guidelines for Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations issued late last year.

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Where did Pharmaceutical GMP start - the "Cutter" episode?
When did the concept of Good Manufacturing Practice start? Can one trace the origins back to the 1930s, or back as far as the pyramids? We'd find evidence of it there too I think.

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A GMP Compliant Quality System for a Combination Product
Drug-device combination products are a rapidly growing, much ballyhooed healthcare technology. But this technology poses unique challenges for research, manufacturing and quality departments as they strive to understand and respond to the distinct requirements of two FDA regulated products.

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