Manufacturing

GMP

Current Good Manufacturing Practices (cGMP)

Ensure your company meets current good manufacturing practice (cGMP) guidelines set by the U.S. Food and Drug Administration (FDA).

The FDA's cGMP guidelines ensure products are produced in a consistent way. That means production should take place in a controlled environment. Quality standards should guide the intended use of products. With the right cGMP software system, GMP compliance can be simple and continuous.

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Meet GMP quality requirements with cGMP software

cGMP Regulations

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The cGMP regulations describe requirements to be followed by pharmaceutical manufacturers, applicants, and the FDA. The regulations ensure products are safe for use and have the ingredients and strength they claim to have. The FDA enforces multiple GMP quality-related regulations. These include 21 CFR Parts 210-211, which relate to GMP compliance for drug products.

cGMP Software Systems

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CGMP software helps automate and standardize processes to get to market faster. GMP quality systems connect and ensure quality throughout the product life cycle. Information is maintained in a central location. Compliance is simple.

GAMP 5

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GAMP 5 refers to good automated manufacturing practices. It provides guidance to help companies in the pharmaceutical industry determine the best approach for achieving compliant computerized systems.

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Overview of Good Manufacturing Practice Compliance

The cGMP regulations are in place to ensure product quality and consumer safety. CGMP compliance requires that manufacturers sufficiently control their manufacturing operations. This includes establishing a strong QMS and robust operating procedures. Manufacturers can determine the best methods of implementing controls.

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Modern cGMP Systems for GMP Quality

The cGMP guidelines are minimum requirements. They allow some flexibility for manufacturers. This flexibility lets companies use modern GMP quality systems and approaches to improve quality through continuous improvement.

Better cGMP compliance is a click away.

Make sure your cGMP software meets current good manufacturing practice requirements.

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