September 2024 | Avoiding Pitfalls in CMC: The Power of ‘Measure Twice, Cut Once

Running afoul of the adage, “measure twice, cut once” can upend a construction project. But what it can do to a CMC (Chemistry, Manufacturing, and Controls) development program can be much, much worse.  The saying emphasizes the importance of careful planning and verification before taking action. In the context of CMC , this principle is highly relevant and dangerous to ignore. Here are some key pointers: 

1. Thorough Planning: Before initiating any manufacturing process, it’s crucial to have a detailed strategy and plan that includes all necessary steps, materials, and controls. This will ensure that every aspect of the process is well-understood and accounted for. 
2. Rigorous Testing: Risk based characterization of processes and materials before full-scale production helps to efficiently identify potential issues early. This includes analytical method validation, stability testing, and process validation. 
3. Quality Control: Implementing risk-based control measures at every stage of the manufacturing process ensures that any deviations or defects are caught and corrected before they can affect the final product. 
4. Regulatory Compliance: Ensuring that all regulatory requirements are met before submitting documentation to regulatory authorities helps avoid delays and rejections. This involves double-checking all data, documentation, and compliance with applicable guidelines. 
5. Risk Management: Conducting thorough risk assessments and implementing mitigation strategies can prevent costly mistakes and ensure the safety and efficacy of the drug product. 

By applying the “measure twice, cut once” philosophy, a CMC development program can efficiently minimize errors, reduce waste and delays, and ensure a higher quality product while speeding time to market. Contact us at Windshire or Labshire and let us help you with your CMC needs and more.