What Are CGMP Guidelines? (Plus Tips for Adhering to Them)

By Indeed Editorial Team

Published March 25, 2022

The Indeed Editorial Team comprises a diverse and talented team of writers, researchers and subject matter experts equipped with Indeed's data and insights to deliver useful tips to help guide your career journey.

Safety and quality are of the utmost importance within the food and drug industry. There are specific guidelines that companies abide by when producing and selling such products. Learning about these guidelines may help you understand the requirements that businesses have when producing food and drug products. In this article, we discuss what CGMPs are, describe why they're important, explore their components and share tips for adhering to them.

What are CGMPs?

CGMPs are guidelines made by the Food and Drug Administration (FDA) that enforce the quality of the production, manufacturing and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements and medical devices. CGMP stands for Current Good Manufacturing Practices. Companies focus on continuously developing practices and systems to adhere to CGMPs and ensure patient and customer safety when consuming and using products.

Why are CGMPs important?

CGMPs are important because they ensure that products consistently meet the quality and safety standards for consumption. CGMPs also ensure that companies can manufacture each of their products in a manner that follows FDA regulations. These regulations allow manufacturers to remain competitive in their industries, and they protect customers from being exposed to unsafe products.

It's especially critical to follow these guidelines when developing medical and pharmaceutical products to ensure that they're effective and safe for any patients who are receiving treatment. For example, CGMPs can prevent food poisoning by ensuring that food manufacturers don't allow microbes or pathogens to grow in their facilities.

Related: FAQ: Working as a Manufacturing Process Engineer

How does the FDA ensure companies adhere to CGMP guidelines?

The FDA follows two important steps to ensure companies are following CGMP guidelines. The first step is inspecting a new plant that's first producing a product or inspecting a facility when significant changes occur in the manufacturing process. This requires an FDA inspector to review the facility and determine whether it meets all CGMP standards. If an inspector discovers any violations, they can issue warnings or even close the facility until it corrects its practices.

The second step that the FDA follows is its inspection of each product that's moved from the manufacturing facility to distribution or retail. This inspection of finished products ensures they meet CGMP standards before a company distributes them.

Important components of CGMPs

Here are some important components of CGMP guidelines:

Reliable testing

CGMP guidelines require all companies to test each batch of products to ensure they meet the quality and safety requirements for the product. This type of testing is important because it helps manufacturers see if a batch has the potential for harm before allowing it to enter the market. Reliable testing also gives companies a way to discover any manufacturing defects in their products quickly, which allows them to resolve their issues before a product reaches customers.

Related: 12 Manufacturing Certifications (With Benefits and Tips)

Monitoring of product composition

Each manufacturer also monitors the composition of its products throughout the manufacturing process. This helps them detect any major changes or mistakes that may occur during production so they can correct them before releasing each batch into the market. For example, if a product contains more of a specific ingredient than is normal, the company may remove the product and ensure that it's safe before distributing it.

Deviation control

CGMPs also require companies to use deviation control in their manufacturing processes to ensure that each batch makes it through all the stages of production without being contaminated. Deviation control helps manufacturers identify any defects in their products quickly and allows them to resolve any problems before releasing their product into the market. For example, if a company uses an ingredient that isn't allowed by a CGMP, the company may remove the entire batch from production until the product meets CGMP standards.

Quality materials

CGMPs also require companies to use high-quality raw materials in their manufacturing processes. If a company uses poor-quality raw materials, it may risk producing low-quality or harmful products. It's especially important to use raw materials that meet CGMP standards when creating medical products because any contaminants introduced during manufacturing can cause harm to a patient receiving treatment.

Related: 25 of the Best Pharmaceutical Companies To Work For

Tips for ensuring adherence to CGMP guidelines

Here are some tips for ensuring adherence to CGMP guidelines:

Train team members on CGMP guidelines

Companies can provide their employees with training on the CGMP guidelines to ensure they're aware of how to produce each product properly. By staying current with CGMPs, companies can make sure they release products that meet standards. Companies that follow the CGMP regulations may also encourage their customers to use their products because consumers know they can trust the quality.

Have a quality control system to confirm that your facilities follow CGMP guidelines

Companies can develop an effective quality control system to ensure that their facilities and products comply with CGMP guidelines. An effective quality control system can help companies detect any issues in their facilities or products so they can correct them before releasing each batch into the market. For example, a company may hire a quality control manager to conduct regular quality checks on all its products.

Related: 10 Jobs You Can Get in Pharmaceutical Science

Ensure your plant is designed to follow CGMP guidelines

Companies can ensure their facility design allows them to meet all CGMP requirements. For example, they can enact policies that ensure they clean their facilities regularly and adjust their equipment components as needed to remain compliant. This helps manufacturers maintain a clean environment in which they can produce their products in a way that adheres to the CGMP guidelines.

Conduct self-audits for CGMP adherence

Companies can conduct annual self-audits to make sure they're following CGMP guidelines and ensure they're ready to manufacture a new product. Routine self-audits also help companies identify any issues with their processing or manufacturing processes that might cause potential problems in the future. Safety managers and quality assurance managers are two types of professionals who can conduct these audits.


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