To maintain the safety, efficacy, and consistency of a pharmaceutical or biologic throughout time, it is necessary to specify the production procedures, product features, and product testing that will be used. CMC stands for "chemistry, manufacturing, and control," which describes these processes.
After drug discovery, chemistry manufacturing and controls are involved in every step of the drug development process. Validation of analytical procedures for product monitoring occurs during preclinical drug development. Raw ingredients are selected and examined, physicochemical features of the product are identified, and stability testing can begin. When a drug reaches the clinical phase of development, more characterisation and validation of analytical methods are necessary.
Scaling up production after clinical trials requires strict adherence to the original product's specifications to guarantee that the final product is effective and safe for human use. Following qualification of the production process, lot release and in process testing will proceed.
This area of the resource center delves into the Chemistry Manufacturing Controls Consulting Services that apply to various products. To guarantee that the manufacturing process reliably generates a safe and effective product that meets or exceeds the parameters set forth in the NDA, there are distinct but related requirements for small molecules, large molecules, and gene therapy products.
What is a CMC designed Process?
A CMC process must be developed to ensure that manufacturing standards have been established prior to human testing of a pharmaceutical product. Module 3 of the CTA necessitates this data for submission to regulatory bodies in Europe and the United States alike, including the Investigational Medicinal Product (IMPD) and the Investigational New Drug (IND) applications, respectively, as well as EU MAAs and NDAs/BLAs for approval in those regions.
To ensure that the product utilized in clinical research consulting trials and the batches manufactured for commercial purposes are same in identity, safety, quality, stability, and strength, regulatory agencies require precise requirements.
Must CMC Procedures Be Followed?
Lifecycle management operations and chemistry manufacturing and control, such as technology transfer and line extensions, are included in the CMC process and must be adhered to by all firms holding investigational drugs at all times. To fully grasp the required CMC approach, one must be aware of which manufacturing process steps and factors must be managed and why.
The Repercussions of Failing to Comply with CMC Regulations
The marketing authorization can be revoked for noncompliance with CMC procedures or if they do not fulfill current regulatory criteria. The relevant regulatory bodies may levy fines, halt distribution, and require that any information gaps be filled in.
To remain in accordance with the agency's most recent recommendations, your chemistry manufacturing and controls certification will need to be regularly updated to reflect the most recent regulatory requirements.
Should You Develop Your Strategy With the Help of a CMC Consultant?
By enlisting the aid of a global partner versed in regulatory strategy and CMC development, you may have peace of mind knowing that your product's safety, efficacy, and consistency have all been well evaluated and documented.
Supporting the successful design of your CMC plan, including process and formulation development, analytical development, identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP), developing control strategies, establishing quality testing methods, and reviewing validation protocols and reports, is our science-first approach to understanding your product combined with first-hand insights of regulatory expectations and requirements.
You may rest assured that you are following the most up-to-date FDA and European Medicines Agency (EMA)/national agencies instructions thanks to our significant knowledge and regular interaction with these organizations.
Since we know how the regulatory system works, we can decipher the regulatory landscape and use it to craft an effective CMC strategy. We can also assist with scientific guidance and meetings with relevant authorities, in which we can prepare, coordinate, and participate.
