CMC

Chemical, Manufacturing and Control (CMC)
Sri Harsha Gonnuru
Student of online Professional degree in pharmaceutical regulatory affairs (PDPRA), James Lind
Institute, India
The objective of this paper is to outline Chemical, Manufacturing and Control (CMC) and pre-
Ind meeting regarding CMC.
Chemical, Manufacturing and Control (CMC):
CMC stands for Chemistry, Manufacturing and Controls. A very important part of a
pharmaceutical clinical trial or marketing application is the Chemistry, manufacturing and controls
(CMC) section. Chemistry, Manufacturing and Controls (CMC) of a medicinal product is the body
of information that defines not only the manufacturing process itself but withal the quality control
release testing, designations and stability of the product together with the manufacturing facility
and all of its support utilities, including their design, qualification, operation and maintenance 1.
All stages of the drug development life cycle, after drug revelation involve CMC. During
preclinical drug development, the opportune analytical methods are validated to monitor the
product. Stability testing may be initiated, the physicochemical properties of the product are
resolute, raw materials are culled and tested. When the drug development process moves into the
clinical stage, further analytical method validation is required, and supplemental characterization
of the drug product is needed. After clinical tribulations the scale-up process must ascertain that
the more immensely colossal batches of product are identically tantamount and meet the same
designations as the drug tested in the clinical tribulations. After the manufacturing process is
eligible, lot release and in process testing will perpetuate to take place2. The timeline for drug
development is depicted below, this shows the clear importance of CMC in drug development3.
Pre Ind meeting about CMC:
Sponsors probing for pre-IND guidance must request a Type B meeting with the FDA, which can
be an opportunity to build a relationship with the FDA and gain valuable feedback on any questions
regarding drug development. Albeit the FDA does not require these meetings, they are
recommended because such meetings can attest the requisites of the development process. It may
be benign to meet with the FDA early in the drug development process so that any
recommendations and answers to questions can be integrated into the development program. These
meetings are most efficacious when they are fixated on concrete scientific or regulatory issues,
such as clinical tribulation design, pharmacology studies, toxicology studies, acceptability of novel
formulations, dosing circumscriptions, data requisites for an IND application, and regulatory
requisites for demonstrating safety and efficacy to fortify an incipient drug approbation5. With
veneration to CMC information, the purport of pre-IND meetings for phase 1/phase 2 is to discuss
safety issues cognate to the opportune identification, vigor, quality, purity, or potency of the
investigational drug, as well as to identify potential clinical hold issues4. Conventionally the format
of meetings prior to and during the IND stage is multidisciplinary, involving Agency personnel in
clinical, pharmacology, pharmacokinetics, chemistry, microbiology, statistics, and other
disciplines. Sufficient time should be allotted during multidisciplinary meetings to discuss CMC
issues. Of consequentiality are CMC-cognate issues that affect other disciplines. The sponsor can
provide a brief initiatory presentation of CMC information; however, the majority of the meeting
time allotted to CMC should be habituated to discuss concrete CMC issues. Congruous technical
experts (e.g., chemists, microbiologists, biologists) representing the sponsor and the Agency
should be present during all discussions of CMC-cognate issues4. Under congruous circumstances,
a separate CMC-categorical meeting can be held in additament to, or as an alternative to, the
multidisciplinary format. For example, a CMC-categorical meeting is inspirited to discuss CMC
issues that are too extensive or detailed to be adequately addressed in a multidisciplinary meeting
or are otherwise beyond the scope of a multidisciplinary meeting4.
The conference should also include a debate on the drug's multiple science and regulatory eleme
nts as they relate to safety and/or prospective clinical retention problems.Examples of the CMC p
roblems that could be addressed in pre-IND conferences are:
1. Physical, chemical, and/or biological characteristics

2. Manufacturers
3. Source and method of preparation
4. Removal of toxic reagents
5. Quality controls (e.g., identity, assay, purity, impurities profile)
6. Formulation
7. Sterility (e.g., sterilization process, release sterility and endotoxin testing, if
8. applicable)
9. Linkage of pharmacological and/or toxicity batches to clinical trial batches
10. Stability information
References:
1. An introduction to CMC regulatory compliance - genpact.com. (n.d.). Retrieved from

https://www.genpact.com/insight/blog/an-introduction-to-cmc-regulatory-compliance.
2. CMC – Chemistry, Manufacturing and Controls. (n.d.). Retrieved from
https://pacificbiolabs.com/cmc-chemistry-manufacturing-and-controls.
3. Saturday, A. 30. (2016, April 30). Preclinical Development: The Safety Hurdle Prior to
Human Trials. Retrieved from http://www.americanpharmaceuticalreview.com/Featured-
Articles/187349-Preclinical-Development-The-Safety-Hurdle-Prior-to-Human-Trials/.
4. U.S. Food and Drug Administration. (2019). What information is provided to sponsors
during the human drug product application review process? | FDA. [online] Available at:
https://www.fda.gov/industry/fda-basics-industry/what-information-provided-sponsors-
during-human-drug-product-application-review-process [Accessed 3 Oct. 2019].
5. The Basics of a Pre-IND Meeting. (n.d.). Retrieved from
https://www.oraclinical.com/resource/the-basics-of-a-pre-ind-meeting/.

CMC

Uploaded by

Copyright:

Available Formats

CMC

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CMC

Uploaded by

Copyright:

Available Formats

What is CMC and what does it involve?

What is the purpose of a pre-IND meeting regarding CMC?

Chemical, Manufacturing and Control (CMC)

Chemical, Manufacturing and Control (CMC)

Sri Harsha Gonnuru

Chemical, Manufacturing and Control (CMC):

Pre Ind meeting about CMC:

1. Physical, chemical, and/or biological characteristics

1. An introduction to CMC regulatory compliance - genpact.com. (n.d.). Retrieved from

You might also like