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 API manufacturing is constructed. It covers quality management, production methods and activities, and packaging, storage and distribution methods.

In addition, the guidance covers how companies must conduct internal audits and quality reviews. It discusses the best practices for validation, materials management, and laboratory controls. Finally, it also covers personnel training and how people are to be qualified and tested for work in GMP API manufacturing. Consultant training and qualifications are also discussed, as are issues of hygiene and emergency response.

How Necessary Is the Guidance?

For GMP quality assurance, for example, clean room standards dictate that no particulate matter of larger than 0.3 micrometers can be present, and particulates of that size or smaller cannot be present in quantities larger than 12 particles per cubit meter. The typical outdoor air in an American urban area contains 35 million particles of 0.5 cubit meters and larger for every cubit meter, meaning that contamination is a huge issue in GMP API manufacturing. Strict GMP quality assurance and GMP standards are necessary to avoid contamination.

In 2012, procedural shortcuts and maintenance and cleaning failures at a pharmacy in the United States led to an outbreak of fungal meningitis. By the time the drug was tracked, isolated, and recalled, nearly 50 people had been killed. This incident highlights the importance of robust GMP API manufacturing standards and proper GMP storage conditions, standards, and practices.

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