NeuAge Institute (NAI)

A Quick Guide to CMC Compliance for Those in Regulatory Affairs Training

Photo illustrating compliance as a key aspect of Regulatory Affairs Training

Pharmaceuticals and biological products require specific manufacturing processes, product characteristics, and product testing to ensure safety, effectiveness, and consistency across batches. This set of activities is called CMC or chemistry, manufacturing, and controls.

Chemistry, manufacturing, and controls are vital aspects of the drug development process. CMC regulatory affairs professionals ensure that pharmaceutical products comply with the relevant laws and regulations.

The NeuAge Institute’s Regulatory Affairs Certificate Program offers practical, applied training to budding regulatory professionals. As a regulatory affairs professional in training, understanding the principles of CMC compliance is critical. This blog post aims to provide a quick guide to CMC compliance for those in regulatory affairs training.

What Is CMC In Regulatory Affairs Training?

CMC are activities related to the development, manufacturing, and testing of pharmaceutical products. CMC compliance ensures that products meet quality, safety, and efficacy standards, and it will be one of your topmost concerns after you earn your regulatory affairs certificate and find employment with any organization in the industry as a regulatory affairs professional. Essentially, CMC encompasses everything from the composition of the drug substance to the packaging of the finished product.

A hand indicating on a clear board that the quality is correct in Regulatory Affairs Training
Quality compliance will be your top priority after regulatory affairs training.

The CMC process begins with the identification and selection of a suitable drug substance. The next step is to develop a formulation that delivers the drug substance at the required dose and with the desired pharmacokinetic properties. Once a suitable formulation has been developed, the manufacturing process must be established, and the product tested to ensure that it meets the required quality standards.

CMC Submission Requirements in Your Regulatory Affairs Career

The FDA is the regulatory agency responsible for approving pharmaceutical products and requires a detailed CMC submission. The submission should provide sufficient information about the drug substance, product, and manufacturing process. The submission should include:

Drug Substance Information

The drug substance information should include the chemical and physical properties, manufacturing process, controls, and analytical methods for the identification and characterization of the drug substance.

Drug Product Information

The drug product information should include the formulation, manufacturing process, packaging, and labeling information. It should also include stability studies and data on the product’s quality attributes.

Manufacturing Information and Analytical Methods

The manufacturing information should include details of the manufacturing process, including the facilities, equipment, and controls used. The submission should also include information on process validation and controls used to ensure product quality and consistency. 

The submission should include details of the analytical methods used to test the drug substance and drug product. The methods should be validated and suitable for their intended use.

Young apprentices taught by their trainer in a lab during Regulatory Affairs Training
Your regulatory affairs certificate empowers you to seek and verify manufacturing information.

Stability Data

The submission should include stability data for the drug substance and drug product. Stability studies should be conducted under various conditions to determine the product’s shelf life and storage requirements.

On a final note, compliance with CMC regulations is an essential part of the drug development process. Understanding CMC compliance and the requirements for submission is critical for a budding industry professional currently undergoing regulatory affairs training. Understanding these principles will enable you to ensure that the pharmaceutical products you are responsible for will meet the required quality, safety, and efficacy standards.

Are you interested in a regulatory affairs career?

Contact the NeuAge Institute to learn how to get started.

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