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Manufacturing

Good Manufacturing Practice (GMP) Guidelines

Let MasterControl help to assure your system complies to the requirements for Good Manufacturing Practice (GMP) guidelines.

The U.S Food and Drug Administration's (FDA) current good manufacturing practice (cGMP) guidelines help ensure that pharmaceutical drugs and other FDA-regulated products are consistently produced in a controlled environment with quality standards guiding their intended use. The cGMP guidelines are meant to maintain the safety and efficacy of products.

Pharmaceutical CGMP for 21st Century
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Free Resources to Learn About Good Manufacturing Practice Guidelines

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8 Best Practices for Compliant and Quick Software Validation in the Cloud

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CDER Official Offers Tips on GMP Inspections

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Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations

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GAMP® 5: A Risk-based Approach to Compliant GxP Computerized Systems

Manufacturing conveyor belt with medical glass bottles

What the FDA's Good Manufacturing Practice Guidelines Are

The FDA devised current good manufacturing practice regulations to establish a foundation for drug product quality. The GMP guidelines are minimum requirements. They are flexible enough to allow manufacturers to make decisions based on their organization’s needs regarding the best methods of implementing the necessary controls.

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Why Good Manufacturing Practice Guidelines Are Important

Good manufacturing practice guidelines exist to help ensure that drug products are safe and that they work as they are supposed to. The FDA enforces GMP guidelines to ensure that life sciences companies are using systems that assure proper design, monitoring and control of manufacturing processes and facilities.

Solutions to Help You Maintain Compliance with GMP Guidelines

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Documents Management

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Training Management Software

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CAPA and Quality Events

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Audit Management Software

Discover what it takes to achieve pharmaceutical GMP success.

Discover what it takes to achieve pharmaceutical GMP success.

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