Preparing for CMC Regulatory Compliance: The Basics & More
Are you familiar with the latest Chemistry, Manufacturing and Controls (CMC) regulatory compliance requirements?
When manufacturing a medical product, there are strict regulations and guidelines for the manufacturing process, the manufacturing facility itself, and any quality control testing. This collection of information is called the CMC.
The CMC landscape and list of requirements continuously and rapidly change. Because of this, compliance with the regulations must be updated and checked regularly. This CMC regulatory compliance is necessary if a product wants to meet both FDA and EMA requirements and expectations.
Any company dealing in pharmaceuticals, biosimilars, or other biologics will need to have a strategy for CMC regulatory compliance prepared. These strategies will serve numerous purposes and should contain 5 specific elements.
What Is CMC Regulatory Compliance?
With a globalized market for pharmaceutical products, it’s necessary to deal with potentially numerous different regulatory agencies. The CMC regulations collect all strategic international regulatory guidelines that have been created to drive the pharmaceutical industry.
Depending on location and product, this could include Quality by Design (QbD), Quality Risk Management (QRM), or Pharmaceutical Quality System (PQS).
Purpose of CMC Regulatory Compliance Strategies
The consequences of non-compliance with CMC regulations could mean loss of approval, delay in approval, or delay in trials. All of these consequences become wasted time and wasted money. This is why having a strategy to stay compliant is a necessity.
By strengthening infrastructure and control systems in place, you can prevent possible non-compliance. Having a strategy to accomplish this goal and stay up-to-date on all rules and regulations can help avoid any of these consequences.
The Five Elements Of A Strategy
For a strategy to remain compliant with all CMC regulations to be effective, 5 core elements should be included:
1. Embrace The Full Spectrum Of CMC Activities
Since CMC encompasses all aspects of a pharmaceutical product, from facility to the process, you must be aware of it all. You should understand how CMC connects to each point in your organization and the task at hand.
2. Address Unique Requirements For Manufacturing
Each specific manufacturing process will have unique requirements. Expect the differences and take your time to become familiar with the ones relevant to all processes you plan on using.
3. Address Unique Requirements For Products
Similar to the second element, each specific biologic product will have unique requirements as well. These should be researched and understood before beginning working with or on a product.
4. Align With Any Other Guidances
Depending on your location and the product you’re manufacturing, there will be other relevant guidances. These could be strategic ICH Q8/Q9/Q10 guidances or something different but it’s important to align your strategies for those as well.
5. Apply Risk-Based Approach
When you take a risk-based approach for these strategies, you will factor in the corporate risk acceptance level into all decisions. Whether connected to the corporate culture or financial situation, this is still a necessary and important aspect of the strategy.
CfPIE: Helping You Prepare For CMC Regulatory Compliance
Our course “CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars” is designed for senior management, directors, managers, supervisors, project planners, and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy.
Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].
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