Category Radiolabeled compounds

The Importance of GMP API Manufacturing Standards

The FDA regularly updates GMP API manufacturing guidance instructions to help manufacturers maintain best practices for producing quality APIs. America is currently the largest national producer of quality chemical products in the world, employing over 800,000 people throughout the chemical and pharmaceutical sectors. This is in part due to the GMP API manufacturing guidelines that keep the industry and its people and products safe.

What Is the FDA’s Good Manufacturing Practice Guidance?

This is a document regularly refreshed and published by the FDA that provides guidance on the good manufacturing practices, or GMPs, necessary for producing the highest quality APIs. The document gives directions and advice for ensuring that GMP API manufacturing quality and purity standards are met.

What Does the Guidance Address?

The guidance document address every aspect of API manufacturing. It lists the requirements for designing a facility and for how all equipment used in GMP A

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