The document discusses Chemistry, Manufacturing, and Controls (CMC) in pharmaceutical development, emphasizing its role in regulatory affairs and ensuring drug quality, safety, and efficacy. It outlines the responsibilities of regulatory agencies and details CMC submission requirements, including manufacturing processes and quality testing. The importance of CMC is highlighted in the context of maintaining compliance and readiness for regulatory inspections.

1. CMC(CHEMISTRY,MANUFACTURING
AND CONTROL)
Presented By :
Dhananjay Roy(M.Pharm, 1st Sem)
Dept. of Pharmaceutics
NIPS, Mirza

2. CONTENTS
 REGULATORY AFFAIRS
 INTRODUCTION ON CMC
 CMC REGULATORY AFFAIRS
 REFERENCES

3. REGULATORY AFFAIRS
 RA plays an important role in development, licensure,
manufacturing and ongoing marketing of
pharmaceutical product.
 Regulatory Affairs is a profession which has developed
from the desire of governments to protect public health,
by controlling the safety and efficacy of products in
including pharmaceuticals, in areas including veterinary
medicines, medical devices, pesticides, agrochemicals,
cosmetics and complementary medicines.

4. INTRODUCTION ON CMC
 CMC stands for Chemistry, Manufacturing, and
controls.
 CMC team has a similar function to the product
development team, focused on the manufacturing
process development, registration, manufacturing
facility & site inspections.
 It ensures compliance to cGMP, GLP & Clinical
practices.
 It also inspect compliance & readiness for regulatory
inspections of the laboratory, clinical & manufacturing
facilities & information technologies.

5. Why is there CMC?
• To assure that the drug sold to the public will have
quality attributes similar to those of the drug
demonstrated to be safe and effective.
• To assure that the quality of the drug meets appropriate
standards and is consistent.
• To assure that the drug which are using is the drug
described on the label

6. Example: CMC regulatory submission may contain information
associated with API and the finished dosage form, including:
 Names and location of manufacturing and testing sites
 Characterization of the API and composition of the dosage forms
 Raw materials used to manufacture the API and finished dosage
form
 Description of the product and process development
 Description of the manufacturing process
 Analytical methods and specifications used for testing and release
of raw materials, in-process controls, container and closure
system, API and dosage form.
 Quality testing, bio equivalence testing
 Release and stability testing data for both API and
the dosage form.

7. CMC REGULATORY AFFAIRS
 The government regulatory agencies typically involved in the
approval process are:-
 The Food and Drug Administration(FDA)
 European Medicines Agency(EMA)
 Japanese Pharmaceuticals and Medical Devices Agency
(PMDA),etc.
 CMC(RA) is a specific area within RA that has the ultimate
responsibility for providing CMC regulatory leadership and
strategy required to achieve regulatory approvals.
 As a strategic function CMC RA collaborates closely with
multiple scientific, technical, quality, and commercial areas within
a company or with external contract manufacturing organisations
(CMOS).

8. REGULATION
21 CFR 312.23(a)(7)(i) –
As appropriate for the particular investigations
covered by the IND, a section describing the
composition, manufacture, and control of the drug
substance and the drug product sufficient CMC
information to assure the proper identification,
quality, purity and strength of the
investigational drug.

9. CMC REVIEW AT IND STAGES
 Primary objectives is to assure the safety of patients,
during all phases of the IND
 PHASE 1 CMC evaluated mainly from the point of
risk to patient.
 PHASE 2 and 3 CMC evaluates and additionally the
linkage of the clinical test product to be
marketed product.

10. OPEN FOR DISCUSSION

11. REFERENCES
 Jeffrey S. Barrett.,2022,Chemistry, Manufacturing and Controls,
Fundamentals of Drug Development,p. 301.
 Norman.R.Schmuff,David.T.Lin,etal.2004,Chemistry,Manufacturin
g and Controls(CMC), Encyclopedia of Statistical Sciences,p. 1-10.
 Thomas J. DiFeo, Ph.D.,2003,Safety and Efficacy: The Role of
Chemistry, Manufacturing and Controls in Pharmaceutical Drug
Development;30(3),p. 247-257.
 Nina S Cauchon, Shirley Oghamian, Soraya Hassanpour, Michael
Abernathy, et al.,2019, A Review on Innovation in Chemistry,
Manufacturing and Controls- A Regulatory perspective from
industry, Journal of Pharmaceutical Sciences ;108(7),p. 2207-2237.

12. THANKS